Last updated on January 2020

Open-Label Dose-Finding Pharmacokinetics Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections

Brief description of study

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

Detailed Study Description

This is a Phase 1, multicenter, open-label, PK, safety and tolerability study of oritavancin in pediatric patients (<18 years of age) with suspected or diagnosed Gram-positive bacterial infections or pediatric patients requiring peri-operative prophylactic antibiotics. Approximately 52 patients will be enrolled at 5-10 US centers. This study will include 5 age cohorts and patients will be entered in a stepwise approach starting with the older age cohort (12-<18 years). The starting dose will be IV oritavancin 15 mg/kg. 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 patients will be enrolled in each cohort except for the birth to <3 month age cohort which will have at least 16 patients 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.

Clinical Study Identifier: NCT02134301

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