NCT02134301

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

An Open Label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age With Suspected or Confirmed Bacterial Infections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Melinta Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric participants (\<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric participants requiring peri-operative prophylactic antibiotics. Approximately 54 participants will be enrolled at 5-10 United States centers. This study will include 5 age cohorts and participants will be entered in a stepwise approach starting with the older age cohort (12 to \<18 years). The starting dose will be intravenous (IV) oritavancin 15 milligrams/kilogram. The safety, tolerability and PK data will be reviewed at the completion of each cohort to ensure safety and determine the appropriate dose for the next age cohort. At least 8 participants will be enrolled in each cohort except for the birth to \<3 month age cohort which will have at least 16 participants enrolled. Three PK samples will be collected over 14 days. The safety follow-up will complete with a 60-day phone call to the caregiver.

Conditions

• Gram-positive Bacterial Infections

Interventions

Type	Name	Description
DRUG	Oritavancin

Timeline

• Start date: 2014-05-01
• Primary completion: 2025-11-04
• Completion: 2025-11-04
• First posted: 2014-05-09
• Last updated: 2025-12-12

Locations

8 sites across 1 country: United States