Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- 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.
- Short title
- Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-02-01
- First posted
- 2018-08-14
- Registry last updated
- 2023-07-17
- Primary completion date
- 2026-01-01
- Start date
- 2024-01-01
- Participants
- 1,004
- Participant count basis
- Estimated
- Planned participants
- 1,004
- Protocol amendments
- Randomisation ratio
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Wockhardt
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT03630081
- ClinicalTrials.gov ID
- NCT03630081
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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)
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)
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Meet the following clinical criteria for either cUTI or AP:
A. cUTI:
-
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
-
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,
- Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
- Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
- 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
- PubMed 33332545Related publication