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New antibiotic vabomere tested in kids with tough UTIs

NCT ID NCT06672978

Disease control Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study tests the safety of an antibiotic called Vabomere in children aged 3 months to 12 years who have complicated urinary tract infections, including kidney infections. The children receive the medicine through an IV while in the hospital. Researchers monitor for side effects and measure how the drug works in the body.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

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

3 months to 11 years

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.

Key Inclusion Criteria: * Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics. * Evidence of pyuria, confirmed by either of the following: * A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or * A urine specimen with either \> 10 white blood cells (WBCs) per microliter from an unspun urine or \> 5 WBCs per high power field from a centrifuged specimen * Symptomatic or asymptomatic cUTI or AP as specified in the protocol. * Acute Pyelonephritis (qualifying symptoms specified in protocol). * Have a pretreatment "baseline" urine specimen obtained for culture by an acceptable method, including suprapubic aspiration (SPA), clean urethral catheterization, in dwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from externally placed urine bags will not be allowed) within 48 hours before the start of the administration of the first dose of IV study drug therapy. * Must, based on the judgment of the Investigator, require hospitalization initially and 7 to14 days of antibacterial therapy for the treatment of the presumed cUTI. Key Exclusion Criteria: * History of hypersensitivity or allergic reaction to beta-lactam antibiotics (for example \[e.g.\], cephalosporins, penicillins, carbapenems, monobactams). * Known Vabomere-resistant gram-negative organism from study-qualifying urine or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal). * Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication. * Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m\^2, as calculated using the updated bedside Schwartz formula. * Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase \> 3 × upper limit normal (ULN), or total bilirubin \> 1.5 × ULN. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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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

  • Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General

    Athens, 11527, Greece

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, 54642, Greece

  • Geo Hospitals LLC

    Tbilisi, 0144, Georgia

  • JSC Georgian Clinics

    Tbilisi, 0159, Georgia

  • JSC Vian

    Batumi, Georgia

  • LTD L. Managadze National Center of Urology

    Tbilisi, Georgia

  • Multiprofile Hospital For Active Treatment, "Vita", Department of Urology

    Sofia, Bulgaria

  • Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven

    Sliven, Bulgaria

  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases

    Gabrovo, 5300, Bulgaria

  • Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases

    Dupnitsa, 2600, Bulgaria

  • Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases

    Pazardzhik, Bulgaria

  • New Hospitals LLC

    Tbilisi, Georgia

  • Papageorgiou General Hospital

    Thessaloniki, Greece

  • St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department

    Trzebnica, 55-100, Poland

  • St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision

    Rzeszów, 35-301, Poland

  • University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462

    Athens, Greece

  • University Hospital Alexandroupolis, Department of Pediatrics

    Alexandroupoli, Greece

  • University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology

    Sofia, Bulgaria

  • University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"

    Zagreb, 10000, Croatia

  • University Hospitals Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106, United States

  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics

    Rousse, Bulgaria

  • University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic

    Plovdiv, Bulgaria

  • University of Nebraska Medical Center, Department of Pediatrics

    Omaha, Nebraska, 68198, United States

  • Vian JSC

    Tbilisi, Georgia

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