Complicated Urinary Tract InfectionPhase 3NCT04979806
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Phase 3 study testing Cefepime-zidebactam (FEP-ZID) and Meropenem in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Wockhardt at 48 sites in 9 countries.
Trial summary
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID 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?
- Cefepime-zidebactam (FEP-ZID) and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 48 sitesin 9 countries
- Study dates
- 28 Aug 2022to 25 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female ≥ 18 years of age
- Provide a signed written informed consent prior to any study-specific procedures
- Meet the clinical criteria for either cUTI or AP
- Requires hospitalization to manage the cUTI or AP
- Agrees to use effective methods of contraception
Who cannot join
- Known or suspected disease that may confound the assessment of efficacy.
- Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
- Rapidly progressive illness such that the subject is unlikely to survive the study period.
- Pregnant or breastfeeding women
- History of a seizure disorder requiring current treatment
- Creatinine clearance < 15 mL/min or on renal dialysis
Show all 9Show fewer
- Neutropenia or elevated liver enzymes
- Hypersensitivity to beta-lactam antibiotics
- Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
Bulgaria9 sites
MHAT Dobrich AD
Dobrich
UMHAT Dr. Georgi Stranski
Pleven
Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv
Plovdiv
Multiprofile Hospital for Active Treatment - KANEV
Rousse
Multiprofile Hospital for Active Treatment (MHAT)- Silistra
Silistra
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
Sofia
UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology
Sofia
Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna
Varna
China8 sites
Hunan Provincial People's Hospital
Changsha
The Second Xiangya Hospital of Central South University
Changsha
West China Hospital, Sichuan University
Chengdu, 610041
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
Deyang People's Hospital
Deyang
General hospital of the PLA northern theater command
Liaoyang
Fudan University Huashan Hospital
Shanghai, 200040
Shaoxing People's Hospital
Shaoxing
India6 sites
Aartham Multi Super Speciality Hospital
Ahmedabad, 380006
Super Speciality Hospital Government Medical College and Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431004
ORIION Citicare Super Speciality Hospital
Chhatrapati Sambhajinagar, 431005
Supe Hearth & Diabetes Hospital & Research Centre
Nashik, Maharashtra, 422002
ACE Hospital and Research Centre
Pune, Maharashtra, 411004
Accord Hospitals
Pune, Maharashtra, 412105
Mexico6 sites
Hospital Angeles Chihuahua
Chihuahua City, 31238
JM Research Cuernavaca
Cuernavaca, 62290
Centro de Investigacion Clinica de Oaxaca (CICLO)
Oaxaca City
Pharmacology & Clinical Research
Querétaro
Arke SMO S.A. de C.V.
Veracruz
Unidad de Atención Médica e Investigación en Salud (Unamis)
Yucatán, C.P 97000
Estonia5 sites
Ida-Viru Central Hospital
Kohtla-Järve
North Estonia Medical Centre Foundation
Tallinn
West Tallinn Central Hospital
Tallinn
Tartu University Hospital
Tartu
South-Estonian Hospital Ltd.
Võru
Lithuania4 sites
Klaipedos university hospital
Klaipėda, LT-92288
Republican Vilnius University hospital
Vilnius
Vilnius city clinical hospital
Vilnius
Vilnius University Hospital Santaros Klinikos
Vilnius
Poland4 sites
Zespol Opieki Zdrowotnej w Boleslawcu
Bolesławiec
SCM Sp. z o.o.
Krakow, 31-559
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii
Lodz, 90-153
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii
Warsaw
Slovakia4 sites
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica
Fakultna nemocnica Nitra
Nitra
Nemocnica Poprad, a.s. Urologicke oddeleni
Poprad
Fakultna nemocnica s poliklinikou Zilina
Žilina
United States2 sites
S&D Clinical Research, LLC
Fort Myers, Florida, 33919
Santos Research Center
Tampa, Florida, 33615
About this study
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 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. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
- Being tested
- Cefepime-zidebactam (FEP-ZID), Meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefepime-zidebactam (FEP-ZID)Drug
3 g (2 g FEP + 1 g ZID) IV q8h
MeropenemDrug
1 g IV q8h
| Study group | Role | What they receive |
|---|---|---|
| Cefepime-zidebactam (FEP-ZID) | Experimental | Not described Receives: Drug: Cefepime-zidebactam (FEP-ZID) |
| Meropenem | Active comparator | Not described Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Overall Success at Test-of-Cure
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)
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)]
Secondary outcomes (7)
Percentage of Subjects With Overall Success at End-of-Treatment
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 (<1000 CFU/mL)
Measured: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at End-of-Treatment
Clinical cure 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 CFU/mL)(CFU)/mL.
Measured: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percent of Subjects With Microbiological Eradication at End-of-Treatment
Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry
Measured: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at Test-of-Cure
Clinical cure 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 CFU/mL)
Measured: Test-of-Cure (Day 17+-2)
Percent of Subjects With Microbiological Eradication at Test-of-Cure
Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial
Measured: Test-of-Cure (Day 17 ± 2 days)
Percentage of Subjects With Clinical Cure at Late Follow-up
Clinical cure 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 CFU/mL)
Measured: Late Follow-up (Day 26 ± 2 days)
Plasma Concentration of FEP-ZID
Plasma samples from ZID-FEP-treated subjects were analyzed to determine concentrations of ZID and FEP using a validated assay. Pharmacokinetic analyses were based on the PK populations at pre-specified time points on Days 1 and 3 (+1).
Measured: On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start28 Aug 2022
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979806
- Sponsor's protocol ID
- W-5222-301
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
- ClinicalTrials.gov ID
- NCT04979806
- Acronym / sponsor ID
- W-5222-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 22 May 2026
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 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 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. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefepime-zidebactam (FEP-ZID) | Experimental | Drug: Cefepime-zidebactam (FEP-ZID) |
| Meropenem | Active comparator | Drug: Meropenem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years of age
- Provide a signed written informed consent prior to any study-specific procedures
- Meet the clinical criteria for either cUTI or AP
- Requires hospitalization to manage the cUTI or AP
- Agrees to use effective methods of contraception
Key exclusion criteria (9 listed)
- Known or suspected disease that may confound the assessment of efficacy.
- Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
- Rapidly progressive illness such that the subject is unlikely to survive the study period.
- Pregnant or breastfeeding women
- History of a seizure disorder requiring current treatment
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 |
|---|---|---|
| Cefepime-zidebactam (FEP-ZID)3 g (2 g FEP + 1 g ZID) IV q8h | Drug | Cefepime-zidebactam (FEP-ZID) |
| Meropenem1 g IV q8h | Drug | Meropenem |
Primary outcome
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 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)
Time frame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]
Collection of number of adverse events.
7 secondary outcomes
Percentage of Subjects With Overall Success at End-of-Treatment
Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at End-of-Treatment
Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percent of Subjects With Microbiological Eradication at End-of-Treatment
Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at Test-of-Cure
Time frame: Test-of-Cure (Day 17+-2)
Percent of Subjects With Microbiological Eradication at Test-of-Cure
Time frame: Test-of-Cure (Day 17 ± 2 days)
Percentage of Subjects With Clinical Cure at Late Follow-up
Time frame: Late Follow-up (Day 26 ± 2 days)
Plasma Concentration of FEP-ZID
Time frame: On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefepime-zidebactam (FEP-ZID) and Meropenem in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Wockhardt at 48 sites in 9 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Bulgaria, China, India, Mexico, Estonia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Overall Success at Test-of-Cure (time frame: Test Of Cure Visit (Day 17 ± 2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.