A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) — Up to 28 days
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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