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RECRUITING
NCT06672978
PHASE2

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

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

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

3 Months - 11 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-06-03

Completion Date

2027-07

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

Meropenem-Vaborbactam

Administered as specified in the treatment arm

DRUG

Antibiotics

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

Locations (24)

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

General Hospital of Thessaloniki "Ippokratio"

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