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

PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

June 3, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

July 31, 2027

Conditions
Acute PyelonephritisComplicated Urinary Tract Infection
Interventions
DRUG

Meropenem-Vaborbactam

Administered as specified in the treatment arm

DRUG

Antibiotics

Administered as prescribed by the study physician in accordance with the local marketing authorizations

Trial Locations (22)

2600

RECRUITING

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

5300

RECRUITING

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

10000

RECRUITING

"University Hospital for Infectious Diseases Dr. Fran Mihaljevic", Zagreb

11527

RECRUITING

"AGIA SOPHIA Childrens Hospital, Children's Hospital Agia Sophia, Infectious Diseases, Pediatrics - General", Athens

54642

RECRUITING

"General Hospital of Thessaloniki Ippokratio", Thessaloniki

68198

RECRUITING

University of Nebraska Medical Center, Department of Pediatrics, Omaha

92868

RECRUITING

Children's Hospital of Orange County, Orange

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

Unknown

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

JSC Vian, Batumi

RECRUITING

LTD L. Managadze National Center of Urology, Tbilisi

RECRUITING

New Hospitals LLC, Tbilisi

RECRUITING

Vian JSC, Tbilisi

0144

RECRUITING

Geo Hospitals LLC, Tbilisi

0159

RECRUITING

JSC Georgian Clinics, Tbilisi

35-301

RECRUITING

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

55-100

RECRUITING

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

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

lead

Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)

INDUSTRY