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

NCT02134301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Gram-positive Bacterial Infections

Interventions

DRUG

Oritavancin

Sponsors & Collaborators

  • Melinta Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Study Director · Melinta Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2025-11-04
Completion
2025-11-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134301 on ClinicalTrials.gov