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Cefepime-zidebactam

Phase 3

Complicated Urinary Tract Infection | Small molecule | Infectious Disease |Medpace Holdings, Inc. Common Stock|Last Updated: May 22, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment530

FDA Designations

No designations recorded

Clinical trial landscape

Cefepime-zidebactam · 1 trial · 2 indications

Phase 3 1
NCT04979806Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)Complicated Urinary Tract Infection
COMPLETED530 Analytics
PHASE3COMPLETED
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Complicated Urinary Tract Infection
NCT04979806530
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Study Endpoints

Primary Endpoints

Percentage of Subjects With Overall Success at Test-of-Cure
Test Of Cure Visit (Day 17 ± 2 days)

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)

Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE)
Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]

Collection of number of adverse events.

Secondary Endpoints

Percentage of Subjects With Overall Success at End-of-Treatment
End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at End-of-Treatment
End of Treatment Visit (Day 7 - 10 ± 1 day)
Percent of Subjects With Microbiological Eradication at End-of-Treatment
End of Treatment Visit (Day 7 - 10 ± 1 day)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cefepime-zidebactam (FEP-ZID)EXPERIMENTAL -
MeropenemACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Cefepime-zidebactam (FEP-ZID)DRUG3 g (2 g FEP + 1 g ZID) IV q8h
MeropenemDRUG1 g IV q8h
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Provide a signed written informed consent prior to any study-specific procedures 3. Meet the clinical criteria for either cUTI or AP 4. Requires hospitalization to manage the cUTI or AP 5. Agrees to use effective methods of contraception E...

Countries:United StatesBulgariaChinaEstoniaIndiaLithuaniaMexicoPolandSlovakia
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