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

Completed · Phase 2 · NCT05599295

Conditions: Acute Bacterial Skin and Skin Structure Infection

At a glance

Research payments reported, 2025
$25,344
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
118

About the trial

Sponsor
Melinta Therapeutics, LLC
Tested
Orbactiv (drug), Kimyrsa (drug)
Dates
Started 2023-06-15; completion 2025-11-20
Results posted
Not yet

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 s…

From ClinicalTrials.gov, last updated 2025-11-25. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Melinta Therapeutics, LLC reported $25,344 in research payments for this study in 2025 (22 payments).

Products named: Kimyrsa, Orbactiv

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • The Research Institute at Nationwide Childrens Hospital $16,781
  • The University of South Florida $8,564

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.