A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Running, not enrolling · Phase 2
Conditions studied: Acute Pyelonephritis, Complicated Urinary Tract Infection
In brief
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).
Key facts
- Study ID
- NCT06672978
- Run by
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
- People needed
- 66
- Starts
- 2025-06-03
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 0 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Children's Hospital of Orange County — Orange, California, United States
- University of Nebraska Medical Center, Department of Pediatrics — Omaha, Nebraska, United States
- University Hospitals Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
- 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
Full record on ClinicalTrials.gov
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