drugset
drugset / Trial / NCT02134301

Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections

NCT02134301 ↗

Phase 1 Completed 41 enrolled Melinta Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants \<18 years old with a confirmed or suspected bacterial infection.

Timeline

Start
2014-05
Primary completion
2025-11-04
Completion
2025-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Oritavancin Other / unclassified 15 mg/kg Intravenous

Indications

gram-positive bacterial infections