RecruitingPhase 2NCT06672978

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

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

Sponsor

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

Enrollment

66 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Complicated urinary tract infection Acute Pyelonephritis

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

Min Age: 3 MonthsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Antibiotics and a drug called Meropenem-Vaborbactam for people with acute pyelonephritis and complicated urinary tract infection. The study is currently recruiting participants at 26 locations. People eligible for this study include aged 3 Months to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMeropenem-Vaborbactam

Administered as specified in the treatment arm

DRUGAntibiotics

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

Locations(26)

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

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

Trzebnica, Poland

View Full Details on ClinicalTrials.gov

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NCT06672978

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