Trial Outcomes & Findings for Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (NCT NCT04979806)
NCT ID: NCT04979806
Last Updated: 2026-05-22
Results Overview
Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
530 participants
Primary outcome timeframe
Test Of Cure Visit (Day 17 ± 2 days)
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Cefepime-zidebactam (FEP-ZID)
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
177
|
|
Overall Study
COMPLETED
|
344
|
174
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Baseline characteristics by cohort
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=352 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=177 Participants
Meropenem: 1 g IV q8h
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 years in MITT population
|
352 Participants
n=2 Participants
|
177 Participants
n=4 Participants
|
529 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=2 Participants
|
79 Participants
n=4 Participants
|
234 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=2 Participants
|
98 Participants
n=4 Participants
|
295 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
311 Participants
n=2 Participants
|
158 Participants
n=4 Participants
|
469 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian Non Chinese
|
93 Participants
n=2 Participants
|
13 Participants
n=4 Participants
|
106 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian Chinese
|
12 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indianor Alaskan Native
|
6 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=2 Participants
|
4 participants
n=4 Participants
|
10 participants
n=6 Participants
|
|
Region of Enrollment
China
|
12 participants
n=2 Participants
|
5 participants
n=4 Participants
|
17 participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
36 participants
n=2 Participants
|
21 participants
n=4 Participants
|
57 participants
n=6 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=2 Participants
|
6 participants
n=4 Participants
|
14 participants
n=6 Participants
|
|
Region of Enrollment
Slovakia
|
12 participants
n=2 Participants
|
9 participants
n=4 Participants
|
21 participants
n=6 Participants
|
|
Region of Enrollment
Bulgaria
|
166 participants
n=2 Participants
|
74 participants
n=4 Participants
|
240 participants
n=6 Participants
|
|
Region of Enrollment
Lithuania
|
67 participants
n=2 Participants
|
26 participants
n=4 Participants
|
93 participants
n=6 Participants
|
|
Region of Enrollment
Estonia
|
22 participants
n=2 Participants
|
19 participants
n=4 Participants
|
41 participants
n=6 Participants
|
|
Region of Enrollment
India
|
23 participants
n=2 Participants
|
13 participants
n=4 Participants
|
36 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Test Of Cure Visit (Day 17 ± 2 days)Population: Overall outcome in mMITT-STIC Population
Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Overall Success at Test-of-Cure
Overall Success at TOC in mMITT-STIC Population
|
250 Participants
|
93 Participants
|
|
Percentage of Subjects With Overall Success at Test-of-Cure
Overall Failure/Indeterminate at TOC in mMITT-STIC Population
|
31 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]Population: Safety Population
Collection of number of adverse events.
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=352 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=177 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE)
|
112 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: End of Treatment Visit (Day 7 - 10 ± 1 day)Population: Overall Outcome at End of Treatment (EOT) (mMITT-STIC Population)
Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (\<1000 CFU/mL)
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Overall Success at End-of-Treatment
Overall Success at End of Treatment (EOT) (mMITT-STIC Population)
|
270 Participants
|
132 Participants
|
|
Percentage of Subjects With Overall Success at End-of-Treatment
Overall Failure/Indeterminate at End of Treatment (EOT) (mMITT-STIC Population)
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: End of Treatment Visit (Day 7 - 10 ± 1 day)Population: Clinical Outcome at End of Treatment (EOT) (mMITT-STIC Population)
Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)(CFU)/mL.
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Clinical Cure at End-of-Treatment
Clinical Response at End of Treatment (EOT) (mMITT-STIC Population)
|
274 Participants
|
133 Participants
|
|
Percentage of Subjects With Clinical Cure at End-of-Treatment
Clinical Non-Response/Indeterminate at End of Treatment (EOT) (mMITT-STIC Population)
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: End of Treatment Visit (Day 7 - 10 ± 1 day)Population: Microbiological Outcome at End of Treatment (EOT) (mMITT-STIC population)
Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial pathogen found at study entry
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percent of Subjects With Microbiological Eradication at End-of-Treatment
Microbiological Eradication at End of Treatment (EOT) (mMITT-STIC population)
|
276 Participants
|
134 Participants
|
|
Percent of Subjects With Microbiological Eradication at End-of-Treatment
Microbiological Persistence/Microbiological Indeterminate at (EOT) (mMITT-STIC population)
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Test-of-Cure (Day 17+-2)Population: Clinical Outcome at Test of Cure (TOC)(mMITT-STIC)
Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Clinical Cure at Test-of-Cure
Clinical Cure at Test of Cure (TOC)(mMITT-STIC)
|
272 Participants
|
129 Participants
|
|
Percentage of Subjects With Clinical Cure at Test-of-Cure
Clinical Failure/Indeterminate at Test of Cure (TOC)(mMITT-STIC)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Test-of-Cure (Day 17 ± 2 days)Population: Microbiologic eradication at Test of Cure (TOC) (mMITT-STIC population)
Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=281 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=136 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percent of Subjects With Microbiological Eradication at Test-of-Cure
Microbiologic eradication at Test of Cure (TOC) (mMITT-STIC population)
|
256 Participants
|
96 Participants
|
|
Percent of Subjects With Microbiological Eradication at Test-of-Cure
Microbiologic persistence/indeterminate at Test of Cure (TOC) (mMITT-STIC population)
|
25 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Late Follow-up (Day 26 ± 2 days)Population: Clinical outcome at Late Follow-up (LFU) in mMITT-STIC population
Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=272 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=129 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Percentage of Subjects With Clinical Cure at Late Follow-up
Sustained Clinical Cure at Late Follow-up (LFU) in mMITT-STIC population
|
264 Participants
|
128 Participants
|
|
Percentage of Subjects With Clinical Cure at Late Follow-up
Clinical Failure/ Clinical Indeterminate at Late Follow-up (LFU) in mMITT-STIC population
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusionPopulation: Pharmacokinetic Evaluation in adult subjects with cUTI or AP
Plasma samples from ZID-FEP-treated subjects were analyzed to determine concentrations of ZID and FEP using a validated assay. Pharmacokinetic analyses were based on the PK populations at pre-specified time points on Days 1 and 3 (+1).
Outcome measures
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=351 Participants
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=351 Participants
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Plasma Concentration of FEP-ZID
Day 3 at 4 hours
|
38.750 ug/mL
Standard Deviation 24.522
|
20.261 ug/mL
Standard Deviation 13.319
|
|
Plasma Concentration of FEP-ZID
Day 3 at 7 hours
|
23.278 ug/mL
Standard Deviation 19.039
|
12.378 ug/mL
Standard Deviation 10.849
|
|
Plasma Concentration of FEP-ZID
Day 4 at 0.5 Hours
|
15.709 ug/mL
Standard Deviation 7.998
|
8.107 ug/mL
Standard Deviation 4.716
|
|
Plasma Concentration of FEP-ZID
Day 4 at 2 Hours
|
54.351 ug/mL
Standard Deviation 19.331
|
28.329 ug/mL
Standard Deviation 10.052
|
|
Plasma Concentration of FEP-ZID
Day 4 at 4 Hours
|
30.469 ug/mL
Standard Deviation 9.963
|
15.664 ug/mL
Standard Deviation 5.529
|
|
Plasma Concentration of FEP-ZID
Day 4 at 7 Hours
|
19.173 ug/mL
Standard Deviation 8.792
|
9.825 ug/mL
Standard Deviation 5.029
|
|
Plasma Concentration of FEP-ZID
Day 1 at 0.25 hours
|
89.400 ug/mL
Standard Deviation 104.665
|
44.941 ug/mL
Standard Deviation 49.569
|
|
Plasma Concentration of FEP-ZID
Day 1 at 2 hours
|
47.375 ug/mL
Standard Deviation 21.522
|
24.461 ug/mL
Standard Deviation 11.252
|
|
Plasma Concentration of FEP-ZID
Day 3 at 0.5 hours
|
19.297 ug/mL
Standard Deviation 17.798
|
10.250 ug/mL
Standard Deviation 9.693
|
|
Plasma Concentration of FEP-ZID
Day 3 at 2 hours
|
61.836 ug/mL
Standard Deviation 47.281
|
31.866 ug/mL
Standard Deviation 22.947
|
Adverse Events
Cefepime-zidebactam (FEP-ZID)
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Meropenem
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=352 participants at risk
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=177 participants at risk
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/352 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.56%
1/177 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.28%
1/352 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.85%
3/352 • Number of events 3 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Infections and infestations
COVID-19
|
0.28%
1/352 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.28%
1/352 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.28%
1/352 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.28%
1/352 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
Other adverse events
| Measure |
Cefepime-zidebactam (FEP-ZID)
n=352 participants at risk
Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h
|
Meropenem
n=177 participants at risk
Meropenem: 1 g IV q8h
|
|---|---|---|
|
Cardiac disorders
HYPERTENTION
|
3.1%
11/352 • Number of events 11 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
15/352 • Number of events 15 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
4.0%
7/177 • Number of events 7 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.85%
3/352 • Number of events 3 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
3.4%
6/177 • Number of events 6 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
5/352 • Number of events 5 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
4/352 • Number of events 4 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.56%
1/177 • Number of events 1 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
General disorders
Pain
|
0.00%
0/352 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
10/352 • Number of events 10 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.57%
2/352 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Nervous system disorders
Headache
|
3.1%
11/352 • Number of events 11 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
5.1%
9/177 • Number of events 9 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Renal and urinary disorders
Hematuria
|
1.1%
4/352 • Number of events 4 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
0.00%
0/177 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/352 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
1.1%
2/177 • Number of events 2 • Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place