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ACTIVE NOT RECRUITING
NCT02687906
PHASE1

Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections

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

View on ClinicalTrials.gov

Summary

A single dose infusion of Vabomere (meropenem-vaborbactam) is being tested for dose-finding, pharmacokinetics, safety, and tolerability in pediatric subjects from birth to less than 18 years of age with serious bacterial infections

Official title: An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years of Age With Serious Bacterial Infections

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2016-07

Completion Date

2025-12

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

DRUG

Vabomere

Vabomere (meropenem-vaborbactam) for IV injection

Locations (9)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutger's University

New Brunswick, New Jersey, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Toledo Children's Hospital

Toledo, Ohio, United States