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New antibiotic combo shows promise against tough UTIs

NCT ID NCT04979806

Disease control Sponsor: Wockhardt Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new antibiotic combination, cefepime-zidebactam, against a standard antibiotic (meropenem) in adults hospitalized with complicated urinary tract infections or kidney infections. About 530 participants received either the new drug or the standard one for 7 to 10 days. The goal was to see if the new antibiotic works as well and is safe. This is a late-stage trial (Phase 3) that has already been completed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

530 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Provide a signed written informed consent prior to any study-specific procedures 3. Meet the clinical criteria for either cUTI or AP 4. Requires hospitalization to manage the cUTI or AP 5. Agrees to use effective methods of contraception Exclusion Criteria: 1. Known or suspected disease that may confound the assessment of efficacy. 2. 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. 3. Rapidly progressive illness such that the subject is unlikely to survive the study period. 4. Pregnant or breastfeeding women 5. History of a seizure disorder requiring current treatment 6. Creatinine clearance \< 15 mL/min or on renal dialysis 7. Neutropenia or elevated liver enzymes 8. Hypersensitivity to beta-lactam antibiotics 9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis bacterial urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pyelonephritis Complicated urinary tract infection

Contacts and locations

Locations

  • ACE Hospital and Research Centre

    Pune, Maharashtra, 411004, India

  • Aartham Multi Super Speciality Hospital

    Ahmedabad, 380006, India

  • Accord Hospitals

    Pune, Maharashtra, 412105, India

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, Bulgaria

  • Arke SMO S.A. de C.V.

    Veracruz, Mexico

  • Centro de Investigacion Clinica de Oaxaca (CICLO)

    Oaxaca City, Mexico

  • Deyang People's Hospital

    Deyang, China

  • Fakultna nemocnica Nitra

    Nitra, Slovakia

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, Slovakia

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, Slovakia

  • Fudan University Huashan Hospital

    Shanghai, 200040, China

  • General hospital of the PLA northern theater command

    Liaoyang, China

  • Hospital Angeles Chihuahua

    Chihuahua City, 31238, Mexico

  • Hunan Provincial People's Hospital

    Changsha, China

  • Ida-Viru Central Hospital

    Kohtla-Järve, Estonia

  • JM Research Cuernavaca

    Cuernavaca, 62290, Mexico

  • Klaipedos university hospital

    Klaipėda, LT-92288, Lithuania

  • MHAT Dobrich AD

    Dobrich, Bulgaria

  • Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov

    Sofia, Bulgaria

  • Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna

    Varna, Bulgaria

  • Multiprofile Hospital for Active Treatment (MHAT)- Silistra

    Silistra, Bulgaria

  • Multiprofile Hospital for Active Treatment - KANEV

    Rousse, Bulgaria

  • Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv

    Plovdiv, Bulgaria

  • Nemocnica Poprad, a.s. Urologicke oddeleni

    Poprad, Slovakia

  • North Estonia Medical Centre Foundation

    Tallinn, Estonia

  • ORIION Citicare Super Speciality Hospital

    Aurangabad, 431005, India

  • Pharmacology & Clinical Research

    Querétaro, Mexico

  • Republican Vilnius University hospital

    Vilnius, Lithuania

  • S&D Clinical Research, LLC

    Fort Myers, Florida, 33919, United States

  • SCM Sp. z o.o.

    Krakow, 31-559, Poland

  • Santos Research Center

    Tampa, Florida, 33615, United States

  • Shaoxing People's Hospital

    Shaoxing, China

  • South-Estonian Hospital Ltd.

    Võru, Estonia

  • Supe Hearth & Diabetes Hospital & Research Centre

    Nashik, Maharashtra, 422002, India

  • Super Speciality Hospital Government Medical College and Hospital

    Aurangabad, Maharashtra, 431004, India

  • Tartu University Hospital

    Tartu, Estonia

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010, China

  • The Second Xiangya Hospital of Central South University

    Changsha, China

  • UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology

    Sofia, Bulgaria

  • UMHAT Dr. Georgi Stranski

    Pleven, Bulgaria

  • Unidad de Atención Médica e Investigación en Salud (Unamis)

    Yucatán, C.P 97000, Mexico

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii

    Lodz, 90-153, Poland

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, Lithuania

  • Vilnius city clinical hospital

    Vilnius, Lithuania

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • West Tallinn Central Hospital

    Tallinn, Estonia

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii

    Warsaw, Poland

  • Zespol Opieki Zdrowotnej w Boleslawcu

    Bolesławiec, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.