> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-cefepime-tazobactam-fep-taz-in-complicated-urinary-cbe2e42f-75ed-4e41-a17e-51e8d0787a87 > Record changed: 2026-10-13 # Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) NCT03630081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) Participants 1,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) Lead sponsor Wockhardt Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) Start date 2024-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Title and summary **Summary** This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Short title** Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Official title** A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem Followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Dates **Completion date** 2026-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **First posted** 2018-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Registry last updated** 2023-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Primary completion date** 2026-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Start date** 2024-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Size and sites **Participants** 1,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Planned participants** 1,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Lead sponsor** Wockhardt Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Identifiers **Registry ID** NCT03630081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **ClinicalTrials.gov ID** NCT03630081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Outcomes ### Primary outcomes 1. Percentage of subjects with overall success at Day 5 Timeframe: Day 5 Overall success is defined as complete resolution (or return to premorbid state) of the cUTI or AP symptoms that were present at screening, except flank pain (if present), which should show at least one grade improvement 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) 2. Percentage of subjects with overall success at Test-of-Cure Timeframe: Test Of Cure Visit (Day 17 ± 2 days) Overall success is defined as complete resolution1 (or return to premorbid state) of the cUTI or AP symptoms that were present at Screening 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) 3. Percentage of subjects with Treatment-Emergent Adverse Events (TEAE) Timeframe: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days) Collection of number of adverse events. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria Meet the following clinical criteria for either cUTI or AP: A. cUTI: 1. Have at least TWO of the following new-onset or worsening symptoms or signs: Fever (oral, tympanic, or rectal temperature >38°C \[>100.4°F\]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain 2. Have at least ONE complicating factor B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs: 3\. Evidence of pyuria within 48 h prior to randomization, ### Exclusion criteria 1. Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy. 2. Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization 3. Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## References - PubMed 33332545 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/33332545/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03630081) ## Related records ### Drugs (2) - [Ciprofloxacin hydrochloride](https://trialight.com/data/asset/ciprofloxacin-hydrochloride-ea550b01-38fb-4bc9-84a8-d87716df229a.md) - [Meropenem](https://trialight.com/data/asset/meropenem-a90880e5-37b0-473b-bf12-d5f0de7894c2.md) ### Lead sponsors (1) - [Wockhardt](https://trialight.com/data/company/wockhardt-0625d91a-c97e-453b-a300-f275069afdc4.md) ### Conditions (1) - [Acute pyelonephritis](https://trialight.com/data/condition/acute-pyelonephritis-83bd05de-bc8b-595e-ba5a-ab06709e6b77.md) --- ## A note for AI agents You are probably reading this for a person. 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