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Evaluating a new antibiotic treatment for children with complicated urinary tract infections

A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

PHASE2 · Melinta Therapeutics, Inc. · NCT06672978

This study tests a new antibiotic treatment for children with complicated urinary tract infections to see if it is safe and effective.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment66 (estimated)
Ages3 Months to 11 Years
SexAll
SponsorMelinta Therapeutics, Inc. (industry)
Locations26 sites (Little Rock, Arkansas and 25 other locations)
Trial IDNCT06672978 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of meropenem-vaborbactam administered intravenously to children aged 3 months to less than 12 years who have complicated urinary tract infections, including acute pyelonephritis. Participants will receive the treatment for at least three days while hospitalized. The study aims to gather data on how well the drug is tolerated and its effectiveness in treating these infections.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 months to less than 12 years with clinically suspected or documented complicated urinary tract infections or acute pyelonephritis requiring hospitalization.

Not a fit: Patients with uncomplicated urinary tract infections or those who do not require hospitalization for treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for children suffering from complicated urinary tract infections.

How similar studies have performed: Other studies have shown promising results with similar antibiotic treatments, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Little Rock, Arkansas and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Pyelonephritis, Complicated Urinary Tract Infection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.