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Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections

NCT05599295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-11-25

No results posted yet for this study

Summary

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs).

This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).

The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.

Conditions

  • Acute Bacterial Skin and Skin Structure Infection

Interventions

DRUG

Orbactiv

Solution for IV infusion

DRUG

Kimyrsa

Solution for IV infusion

Sponsors & Collaborators

  • Melinta Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2025-11-20
Completion
2025-11-20
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Greece
  • Latvia
  • Lithuania
  • Portugal
  • Romania
  • Spain

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 NCT05599295 on ClinicalTrials.gov