Back to resultsStudy of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Primary Purpose
Complicated Urinary Tract Infection, Acute Pyelonephritis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
WCK 4282 (FEP-TAZ) 4 g
Meropenem
ciprofloxacin 500 mg Optional Oral Switch
Infusion of normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WCK 4282 (FEP-TAZ) 4 g
Meropenem
Arm Description
WCK 4282 (FEP-TAZ) Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
Outcomes
Primary Outcome Measures
Percentage of subjects with overall success at 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
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)
Collection of number of adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630081
Brief 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria
Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection, Acute Pyelonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1004 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WCK 4282 (FEP-TAZ) 4 g
Arm Type
Experimental
Arm Description
WCK 4282 (FEP-TAZ) Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
Arm Title
Meropenem
Arm Type
Active Comparator
Arm Description
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
Intervention Type
Drug
Intervention Name(s)
WCK 4282 (FEP-TAZ) 4 g
Intervention Description
WCK 4282 (FEP-TAZ) 4 g [2 g FEP and 2 g TAZ] IV q8h, infused over 90 min
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
1 g IV q8h, infused over 45 min
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin 500 mg Optional Oral Switch
Intervention Description
ciprofloxacin 500 mg PO q12h
Intervention Type
Other
Intervention Name(s)
Infusion of normal saline
Intervention Description
Infusion of normal saline over 45 min
Primary Outcome Measure Information:
Title
Percentage of subjects with overall success at Day 5
Description
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)
Time Frame
Day 5
Title
Percentage of subjects with overall success at Test-of-Cure
Description
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)
Time Frame
Test Of Cure Visit (Day 17 ± 2 days)
Title
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Description
Collection of number of adverse events.
Time Frame
Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manishkumar D Shah, PhD
Phone
91-22-26596000
Ext
6308
Email
Manish.Shah@wockhardt.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mugdha A Gupta, MMS
Phone
91-22-26596000
Ext
6355
Email
mgupta@wockhardt.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manishkumar D Shah, PhD
Organizational Affiliation
Wockhardt
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33332545
Citation
Isler B, Harris P, Stewart AG, Paterson DL. An update on cefepime and its future role in combination with novel beta-lactamase inhibitors for MDR Enterobacterales and Pseudomonas aeruginosa. J Antimicrob Chemother. 2021 Feb 11;76(3):550-560. doi: 10.1093/jac/dkaa511.
Results Reference
derived
Learn more about this trial
Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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