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

Phase 1 Active not recruiting 39 enrolled Melinta Therapeutics, Inc. Department of Health and Human Services · collab

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2016-07
Primary completion: 2026-12
Completion: 2026-12

Publications

Bradley JS, Harvey H, Stout D, Momper J, Capparelli E, Avedissian SN, Barbato C, Mak RH, Jones TP, Jones D, Le J. Subtherapeutic Meropenem Antibiotic Exposure in Children With Septic Shock Assessed by Noncompartmental Pharmacokinetic Analysis in a Prospective Dataset. Pediatr Crit Care Med. 2025 Apr 1;26(4):e507-e515. doi: 10.1097/PCC.0000000000003698. Epub 2025 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Meropenem-Vaborbactam	Unknown	40 mg/kg	Intravenous
Subject	Meropenem-Vaborbactam	Unknown	60 mg/kg	Intravenous
Subject	Meropenem-Vaborbactam	Unknown	80 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications