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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)
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
Meropenem-Vaborbactam
Administered as specified in the treatment arm
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