Ireland
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Active, not recruiting Phase 2

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

NCT06672978 · tracked via the Priya Life Science Poland tracker
Sponsor
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Phase
Phase 2
Started
2025-06-03
Last updated
2026-09-10

Condition(s) studied

Acute PyelonephritisComplicated Urinary Tract Infection

Investigational drug(s) / intervention(s)

Meropenem-Vaborbactam →Antibiotics

Meropenem-Vaborbactam: Administered as specified in the treatment arm

Antibiotics: Administered as prescribed by the study physician in accordance with local guidelines and regulations.

Study summary

The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

Eligibility

Sex
ALL
Min age
3 Months
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants With Adverse Events (AEs) — Up to 28 days

Trial sites (26)

FacilityCityRegionStatus
Arkansas Children's Hospital Little Rock Arkansas
Children's Hospital of Orange County Orange California
University of Nebraska Medical Center, Department of Pediatrics Omaha Nebraska
University Hospitals Rainbow Babies & Children's Hospital Cleveland Ohio
Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases Dupnitsa Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases Gabrovo Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases Pazardzhik Bulgaria
University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic Plovdiv Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics Rousse Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven Sliven Bulgaria
Multiprofile Hospital For Active Treatment, "Vita", Department of Urology Sofia Bulgaria
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 Croatia
JSC Vian Batumi Georgia
Geo Hospitals LLC Tbilisi Georgia
JSC Georgian Clinics Tbilisi Georgia
LTD L. Managadze National Center of Urology Tbilisi Georgia
New Hospitals LLC Tbilisi Georgia
Vian JSC Tbilisi Georgia
University Hospital Alexandroupolis, Department of Pediatrics Alexandroupoli Greece
Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General Athens Greece
University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462 Athens Greece
General Hospital of Thessaloniki "Ippokratio" Thessaloniki Greece
Papageorgiou General Hospital Thessaloniki Greece
St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision Rzeszów Poland
St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department Trzebnica Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672978 on ClinicalTrials.gov ↗ ← All trials in Poland