Complicated Urinary Tract InfectionPhase 3NCT03630081
Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Phase 3 study testing WCK 4282 (FEP-TAZ) 4 g, Meropenem and ciprofloxacin 500 mg Optional Oral Switch in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Wockhardt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- What is being tested?
- WCK 4282 (FEP-TAZ) 4 g, Meropenem and ciprofloxacin 500 mg Optional Oral Switch
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the following clinical criteria for either cUTI or AP:
- 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
- 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,
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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)
- Being tested
- WCK 4282 (FEP-TAZ) 4 g, Meropenem, ciprofloxacin 500 mg Optional Oral Switch, Infusion of normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 4282 (FEP-TAZ) 4 gDrug
WCK 4282 (FEP-TAZ) 4 g [2 g FEP and 2 g TAZ] IV q8h, infused over 90 min
MeropenemDrug
1 g IV q8h, infused over 45 min
ciprofloxacin 500 mg Optional Oral SwitchDrug
ciprofloxacin 500 mg PO q12h
Infusion of normal salineOther
Infusion of normal saline over 45 min
| Study group | Role | What they receive |
|---|---|---|
| WCK 4282 (FEP-TAZ) 4 g | Experimental | 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 Receives: Drug: WCK 4282 (FEP-TAZ) 4 g; Drug: ciprofloxacin 500 mg Optional Oral Switch |
| Meropenem | Active comparator | Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min Receives: Drug: Meropenem; Drug: ciprofloxacin 500 mg Optional Oral Switch; Other: Infusion of normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 5
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)
Measured: Test Of Cure Visit (Day 17 ± 2 days)
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Collection of number of adverse events.
Measured: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,004 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manishkumar D Shah, PhD, Study director, Wockhardt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630081
- Sponsor's protocol ID
- W-4282-301
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2018
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33332545
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03630081
- Acronym / sponsor ID
- W-4282-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,004 participants (estimated)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WCK 4282 (FEP-TAZ) 4 g | Experimental | Drug: WCK 4282 (FEP-TAZ) 4 g, Drug: ciprofloxacin 500 mg Optional Oral SwitchWCK 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 | Active comparator | Drug: Meropenem, Drug: ciprofloxacin 500 mg Optional Oral Switch, Other: Infusion of normal salineMeropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WCK 4282 (FEP-TAZ) 4 gWCK 4282 (FEP-TAZ) 4 g [2 g FEP and 2 g TAZ] IV q8h, infused over 90 min | Drug | WCK 4282 (FEP-TAZ) 4 g |
| Meropenem1 g IV q8h, infused over 45 min | Drug | Meropenem |
| ciprofloxacin 500 mg Optional Oral Switchciprofloxacin 500 mg PO q12h | Drug | Meropenem, WCK 4282 (FEP-TAZ) 4 g |
| Infusion of normal salineInfusion of normal saline over 45 min | Other | Meropenem |
Primary outcome
Percentage of subjects with overall success at Day 5
Time frame: 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
Time frame: 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)
Time frame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)
Collection of number of adverse events.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Derived from this study: PubMed 33332545Isler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manishkumar D Shah, PhD study director
Wockhardt
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WCK 4282 (FEP-TAZ) 4 g, Meropenem and ciprofloxacin 500 mg Optional Oral Switch in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Wockhardt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manishkumar D Shah, PhD (91-22-26596000 ext. 6308, Manish.Shah@wockhardt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with overall success at Day 5 (time frame: Day 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.