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Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
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
Conditions
Interventions
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