Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia (NCT NCT01371838)
NCT ID: NCT01371838
Last Updated: 2017-09-06
Results Overview
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
848 participants
Primary outcome timeframe
7-20 days after last dose of study drug
Results posted on
2017-09-06
Participant Flow
The enrollment period was from 13 December 2011 to 26 April 2013
Enrolled patients (patients who gave informed consent) were screened for up to 24 hours to ensure eligibility before being randomized
Participant milestones
| Measure |
Ceftaroline 600mg
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Overall Study
STARTED
|
381
|
383
|
|
Overall Study
COMPLETED
|
332
|
317
|
|
Overall Study
NOT COMPLETED
|
49
|
66
|
Reasons for withdrawal
| Measure |
Ceftaroline 600mg
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
27
|
33
|
|
Overall Study
Lost to Follow-up
|
10
|
20
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Investigator Decision
|
3
|
8
|
|
Overall Study
Last follow-up visit not conducted
|
2
|
0
|
|
Overall Study
Lack of therapeutic response
|
0
|
1
|
|
Overall Study
Surgery
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
Baseline characteristics by cohort
| Measure |
Ceftaroline 600mg
n=381 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=382 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
Total
n=763 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 Years
STANDARD_DEVIATION 14.70 • n=39 Participants
|
65.8 Years
STANDARD_DEVIATION 13.86 • n=41 Participants
|
66.0 Years
STANDARD_DEVIATION 14.28 • n=35 Participants
|
|
Age, Customized
<65 years
|
155 Participants
n=39 Participants
|
146 Participants
n=41 Participants
|
301 Participants
n=35 Participants
|
|
Age, Customized
>=65 years
|
226 Participants
n=39 Participants
|
236 Participants
n=41 Participants
|
462 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=39 Participants
|
110 Participants
n=41 Participants
|
226 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
265 Participants
n=39 Participants
|
272 Participants
n=41 Participants
|
537 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
381 Participants
n=39 Participants
|
382 Participants
n=41 Participants
|
763 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 7-20 days after last dose of study drugPopulation: CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome).
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Outcome measures
| Measure |
Ceftaroline 600mg
n=258 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=240 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
Clinical Cure
|
217 Participants
|
178 Participants
|
|
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
Clinical Failure
|
41 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Last day of study drug administrationPopulation: All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Outcome measures
| Measure |
Ceftaroline 600mg
n=381 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=382 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Clinical Cure
|
321 Participants
|
281 Participants
|
|
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Clinical Failure
|
45 Participants
|
82 Participants
|
|
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Indeterminate
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Last day of study drug administrationPopulation: CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome).
Outcome measures
| Measure |
Ceftaroline 600mg
n=258 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=240 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at End of Treatment (EOT) Visit in CE Population
Clinical Cure
|
222 Participants
|
186 Participants
|
|
Clinical Response at End of Treatment (EOT) Visit in CE Population
Clinical Failure
|
36 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Outcome measures
| Measure |
Ceftaroline 600mg
n=381 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=382 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Clinical Cure
|
305 Participants
|
256 Participants
|
|
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Clinical Failure
|
53 Participants
|
91 Participants
|
|
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Indeterminate
|
23 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).
Outcome measures
| Measure |
Ceftaroline 600mg
n=80 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=96 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Clinical Cure
|
68 Participants
|
67 Participants
|
|
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Clinical Failure
|
9 Participants
|
21 Participants
|
|
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Indeterminate
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.
Outcome measures
| Measure |
Ceftaroline 600mg
n=57 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=62 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit in ME Population
Clinical Cure
|
50 Participants
|
47 Participants
|
|
Clinical Response at the Test of Cure (TOC) Visit in ME Population
Clinical Failure
|
7 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last dose of study drugPopulation: ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.
Outcome measures
| Measure |
Ceftaroline 600mg
n=57 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=62 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Failure - Haemophilus influenzae
|
1 Participants
|
1 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Klebsiella pneumoniae
|
14 Participants
|
16 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Cure - Klebsiella pneumoniae
|
11 Participants
|
12 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Failure - Klebsiella pneumoniae
|
3 Participants
|
4 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Escherichia coli
|
3 Participants
|
6 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Staphylococcus aureus
|
4 Participants
|
4 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Cure - Staphylococcus aureus
|
4 Participants
|
2 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Failure - Staphylococcus aureus
|
0 Participants
|
2 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Streptococcus pneumoniae
|
22 Participants
|
15 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Cure - Streptococcus pneumoniae
|
19 Participants
|
13 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Failure - Streptococcus pneumoniae
|
3 Participants
|
2 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Cure - Escherichia coli
|
3 Participants
|
5 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Failure - Escherichia coli
|
0 Participants
|
1 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Haemophilus influenzae
|
12 Participants
|
7 Participants
|
|
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Clinical Cure - Haemophilus influenzae
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last dose of study drugPopulation: ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.
Outcome measures
| Measure |
Ceftaroline 600mg
n=57 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=62 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Staphylococcus aureus
|
4 Participants
|
4 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Favourable - Staphylococcus aureus
|
4 Participants
|
2 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Unfavourable - Staphylococcus aureus
|
0 Participants
|
2 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Favourable - Haemophilus influenzae
|
11 Participants
|
6 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Unfavourable - Haemophilus influenzae
|
1 Participants
|
1 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Streptococcus pneumoniae
|
22 Participants
|
15 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Favourable - Streptococcus pneumoniae
|
19 Participants
|
13 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Unfavourable - Streptococcus pneumoniae
|
3 Participants
|
2 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Escherichia coli
|
3 Participants
|
6 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Favourable - Escherichia coli
|
3 Participants
|
5 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Unfavourable - Escherichia coli
|
0 Participants
|
1 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Haemophilus influenzae
|
12 Participants
|
7 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Klebsiella pneumoniae
|
14 Participants
|
16 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Favourable - Klebsiella pneumoniae
|
11 Participants
|
12 Participants
|
|
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Unfavourable - Klebsiella pneumoniae
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Outcome measures
| Measure |
Ceftaroline 600mg
n=80 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=96 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
Favourable
|
68 Participants
|
67 Participants
|
|
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
Unfavourable
|
9 Participants
|
21 Participants
|
|
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
Indeterminate
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Outcome measures
| Measure |
Ceftaroline 600mg
n=57 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=62 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
Favourable
|
50 Participants
|
47 Participants
|
|
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
Unfavourable
|
7 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last day of study drug administrationPopulation: All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Outcome measures
| Measure |
Ceftaroline 600mg
n=381 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=382 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Success
|
305 Participants
|
256 Participants
|
|
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Failure
|
53 Participants
|
91 Participants
|
|
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Indeterminate
|
23 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 7-20 days after last dose of study drugPopulation: CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome).
Outcome measures
| Measure |
Ceftaroline 600mg
n=258 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=240 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Success
|
217 Participants
|
178 Participants
|
|
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Failure
|
41 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 21-42 days after last day of study drug administrationPopulation: All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.
Outcome measures
| Measure |
Ceftaroline 600mg
n=305 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=256 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Clinical relapse
|
286 Participants
|
244 Participants
|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
No Clinical relapse
|
7 Participants
|
5 Participants
|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Indeterminate
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 21-42 days after last day of study drug administrationPopulation: CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome). For this measure only patients who were cured at TOC could be assessed for relapse.
Outcome measures
| Measure |
Ceftaroline 600mg
n=217 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=178 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Clinical relapse
|
199 Participants
|
167 Participants
|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
No Clinical relapse
|
6 Participants
|
3 Participants
|
|
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Indeterminate
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 21-42 days after last dose of study drugPopulation: mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).
Outcome measures
| Measure |
Ceftaroline 600mg
n=80 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=96 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Super-Infection
|
0 Participants
|
2 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Favourable response at TOC
|
68 Participants
|
67 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
No Re-Infection Or Recurrance
|
68 Participants
|
66 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Re-Infection Or Recurrance
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 21-42 days after last dose of study drugPopulation: ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations
Outcome measures
| Measure |
Ceftaroline 600mg
n=57 Participants
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=62 Participants
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Re-Infection Or Recurrance
|
0 Participants
|
1 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Super-Infection
|
0 Participants
|
1 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Favourable response at TOC
|
50 Participants
|
47 Participants
|
|
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
No Re-Infection Or Recurrance
|
50 Participants
|
46 Participants
|
Adverse Events
Ceftaroline 600mg
Serious events: 30 serious events
Other events: 24 other events
Deaths: 0 deaths
Ceftriaxone 2g
Serious events: 29 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ceftaroline 600mg
n=381 participants at risk
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=383 participants at risk
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
General disorders
ASTHENIA
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
General disorders
PYREXIA
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
ASPERGILLOSIS
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
LUNG INFECTION
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.52%
2/383 • Number of events 2 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
TUBERCULOSIS
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
GOUT
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.78%
3/383 • Number of events 3 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Nervous system disorders
COMA
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Nervous system disorders
DIZZINESS
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.52%
2/381 • Number of events 2 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIECTASIS
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.52%
2/381 • Number of events 2 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
1.6%
6/383 • Number of events 6 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.52%
2/381 • Number of events 2 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
HYPERTENSIVE EMERGENCY
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
SHOCK
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.26%
1/381 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.00%
0/383 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.00%
0/381 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
0.26%
1/383 • Number of events 1 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
Other adverse events
| Measure |
Ceftaroline 600mg
n=381 participants at risk
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
|
Ceftriaxone 2g
n=383 participants at risk
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.3%
24/381 • Number of events 24 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
3.4%
13/383 • Number of events 13 • first dose, throughout the treatment period, and up to the TOC visit
All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
|
Additional Information
Melnick, David A / Exec Dir Med Science
AstraZeneca Pharmaceuticals
Phone: +1 302 886 5627
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER