Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants (NCT NCT04335539)
NCT ID: NCT04335539
Last Updated: 2026-02-27
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Day 1 up to Day 28
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Single-Dose Phase: Cohort 1 (12 to <18 Years)
Participants received a single dose of cefiderocol administered as an intravenous (IV) infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
|---|---|---|---|---|---|---|---|
|
Single-Dose Phase (Day 1)
STARTED
|
0
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Single-Dose Phase (Day 1)
Received at Least 1 Dose of Study Drug
|
0
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Single-Dose Phase (Day 1)
COMPLETED
|
0
|
6
|
6
|
6
|
6
|
0
|
0
|
|
Single-Dose Phase (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Multiple-Dose Phase (Up to 14 Days)
STARTED
|
6
|
0
|
0
|
0
|
0
|
12
|
11
|
|
Multiple-Dose Phase (Up to 14 Days)
Received at Least 1 Dose of Study Drug
|
6
|
0
|
0
|
0
|
0
|
12
|
11
|
|
Multiple-Dose Phase (Up to 14 Days)
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
12
|
10
|
|
Multiple-Dose Phase (Up to 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Single-Dose Phase: Cohort 1 (12 to <18 Years)
Participants received a single dose of cefiderocol administered as an intravenous (IV) infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
|---|---|---|---|---|---|---|---|
|
Multiple-Dose Phase (Up to 14 Days)
Protocol deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
Baseline characteristics by cohort
| Measure |
Single-Dose Phase: Cohort 1 (12 to <18 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
n=11 Participants
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=24 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=565 Participants
|
12 Participants
n=349 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=10 Participants
|
53 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=24 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=565 Participants
|
9 Participants
n=349 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=10 Participants
|
34 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=565 Participants
|
3 Participants
n=349 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=24 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=565 Participants
|
12 Participants
n=349 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=10 Participants
|
53 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=565 Participants
|
1 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=24 Participants
|
6 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=565 Participants
|
11 Participants
n=349 Participants
|
11 Participants
n=4 Participants
|
3 Participants
n=10 Participants
|
43 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=565 Participants
|
0 Participants
n=349 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28Population: Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Single-Dose Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 42Population: Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs reported after the initial dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=11 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple-Dose Phase: Number of Participants With TEAEs
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The Pharmacokinetic (PK) Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Single Dose Phase: Maximum Observed Plasma Concentration (Cmax) of Cefiderocol
|
72.1 micrograms (µg)/milliliter (mL)
Geometric Coefficient of Variation 20.1
|
102 micrograms (µg)/milliliter (mL)
Geometric Coefficient of Variation 22.2
|
82.1 micrograms (µg)/milliliter (mL)
Geometric Coefficient of Variation 21.5
|
94.5 micrograms (µg)/milliliter (mL)
Geometric Coefficient of Variation 12.1
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Single Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to Infinity (AUCinf) of Cefiderocol
|
306.9 µg*hours/mL
Geometric Coefficient of Variation 24.6
|
418.8 µg*hours/mL
Geometric Coefficient of Variation 37.0
|
338.0 µg*hours/mL
Geometric Coefficient of Variation 21.7
|
402.3 µg*hours/mL
Geometric Coefficient of Variation 12.5
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Single Dose Phase: Apparent Terminal Elimination Half-life (t1/2) of Cefiderocol
|
3.44 hours
Geometric Coefficient of Variation 9.2
|
4.25 hours
Geometric Coefficient of Variation 12.4
|
4.65 hours
Geometric Coefficient of Variation 9.7
|
5.09 hours
Geometric Coefficient of Variation 4.3
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=10 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple Dose Phase: Cmax of Cefiderocol
|
93.0 µg/mL
Geometric Coefficient of Variation 28.7
|
111 µg/mL
Geometric Coefficient of Variation 34.1
|
97.9 µg/mL
Geometric Coefficient of Variation 15.6
|
—
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=10 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple Dose Phase: Area Under the Plasma Concentration Time Curve Extrapolated From Time 0 to the Last Measurable Concentration (AUC0-t) of Cefiderocol
|
353.1 µg*hours/mL
Geometric Coefficient of Variation 27.9
|
479.4 µg*hours/mL
Geometric Coefficient of Variation 51.9
|
407.2 µg*hours/mL
Geometric Coefficient of Variation 18.1
|
—
|
PRIMARY outcome
Timeframe: Up to 8 hours postdosePopulation: The PK Concentration Population included all enrolled participants who received at least 1 dose of cefiderocol and had at least 1 PK blood sample.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=10 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple Dose Phase: t1/2 of Cefiderocol
|
4.25 hours
Geometric Coefficient of Variation 10.5
|
4.91 hours
Geometric Coefficient of Variation 19.1
|
5.21 hours
Geometric Coefficient of Variation 5.2
|
—
|
SECONDARY outcome
Timeframe: End of treatment (EOT; up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and end of study (EOS; 28 days after last dose [up to Day 42])Population: The Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of cefiderocol.
The clinical outcomes were clinical cure, clinical failure, and indeterminate. Clinical Cure: Resolution or substantial improvement of baseline signs and symptoms. Participants with bacteremia must have had eradication of bacteremia caused by the Gram-negative pathogen. Clinical Failure: No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms, reappearance of signs and/or symptoms; development of new signs and/or symptoms requiring antibiotic therapy other than, or in addition to, study treatment therapy; or death due to pneumonia/complicated intra-abdominal infection (cIAI) or complicated urinary tract infections (cUTI) or bloodstream infection (BSI)/sepsis. Indeterminate: Lost to follow-up such that a determination of clinical cure/failure could not be made.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=11 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOT · Clinical failure
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
Post-treatment · Clinical cure
|
10 Participants
|
9 Participants
|
6 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOT · Clinical cure
|
12 Participants
|
11 Participants
|
6 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOT · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
Post-treatment · Clinical failure
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
Post-treatment · Indeterminate
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOS · Clinical cure
|
12 Participants
|
10 Participants
|
5 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOS · Clinical failure
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Clinical Outcome, as Assessed by the Investigator
EOS · Indeterminate
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: EOT (up to Day 14), post-treatment (7 days after EOT [up to Day 21]), and EOS (28 days after last dose [up to Day 42])Population: The Microbiological Intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of cefiderocol and who had a baseline Gram-negative pathogen from any specimen from a baseline infection site.
Microbiological outcomes were eradication, persistence, and indeterminate. For hospital-acquired pneumonia (HAP)/ventilator-acquired pneumonia (VAP)/cIAI and BSI/sepsis- Eradication: Absence of baseline Gram-negative pathogen from an appropriate clinical specimen; Persistence: Continued presence of baseline Gram-negative pathogen from an appropriate clinical specimen; Indeterminate: No culture obtained from an appropriate clinical specimen or additional antibiotic therapy for the treatment of current infection including missed sampling. For cUTI- Eradication: A urine culture showed baseline Gram-negative uropathogen found at entry at ≥10\^5 colony forming units (CFU)/milliliters (mL) was reduced to \<10\^3 CFU/mL; Persistence: A urine culture showed that the baseline Gram-negative uropathogen found at entry at ≥10\^5 CFU/mL remained at ≥10\^3 CFU/mL; Indeterminate: No urine culture obtained or additional antibiotic therapy for the treatment of current infection including missed sampling.
Outcome measures
| Measure |
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=7 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=8 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=3 Participants
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
|---|---|---|---|---|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
Post-treatment · Eradication
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOS · Persistence
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOT · Eradication
|
5 Participants
|
6 Participants
|
1 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOT · Persistence
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOT · Indeterminate
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
Post-treatment · Persistence
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
Post-treatment · Indeterminate
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOS · Eradication
|
5 Participants
|
6 Participants
|
3 Participants
|
—
|
|
Multiple-Dose Phase: Number of Participants With a Microbiological Outcome, as Assessed by the Investigator
EOS · Indeterminate
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
Adverse Events
Single-Dose Phase: Cohort 1 (12 to <18 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-Dose Phase: Cohort 2 (6 to <12 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single-Dose Phase: Cohort 3 (2 to <6 Years)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-Dose Phase: Cohort 1 (12 to <18 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
n=11 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
Other adverse events
| Measure |
Single-Dose Phase: Cohort 1 (12 to <18 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 2 (6 to <12 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 3 (2 to <6 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Single-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 participants at risk
Participants received a single dose of cefiderocol administered as an IV infusion on Day 1, in addition to standard of care. The dose of cefiderocol for the Single-dose Phase was determined based on body weight only.
|
Multiple-Dose Phase: Cohort 2 (6 to <12 Years)
n=12 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 3 (2 to <6 Years)
n=11 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
Multiple-Dose Phase: Cohort 4 (3 Months to <2 Years)
n=6 participants at risk
Participants received cefiderocol administered via IV infusion on Day 1 then subsequently received cefiderocol every 8 hours as an IV infusion for 5 to 14 days in addition to standard of care. The dose for the Multiple-dose Phase was determined based on both body weight and renal function.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
8.3%
1/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Product Issues
Device connection issue
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
9.1%
1/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
8.3%
1/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/12 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
0.00%
0/11 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
16.7%
1/6 • Single-dose Phase: Day 1 up to Day 28 Multiple-dose Phase: Day 1 up to Day 42
Safety population included all enrolled participants who received at least 1 dose of cefiderocol.
|
Additional Information
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi Inc.
Phone: 800-849-9707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PIs center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 45 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER