A Phase 2 interventional study of Orbactiv and Kimyrsa in Acute Bacterial Skin and Skin Structure Infection, sponsored by Melinta Therapeutics, LLC. Completed at 23 sites in 8 countries. Open to participants aged 3 Months to 11 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Melinta Therapeutics, LLC · Phase 2, Interventional, and Treatment
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.
Melinta Therapeutics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen):
ABSSSI must present with at least 2 of the following signs and symptoms:
and at least 1 of the following signs of systemic inflammation:
Exclusion Criteria:
Participants with ABSSSI due to, or associated with any of the following:
Orbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg.
Drug: Orbactiv
Kimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg.
Drug: Kimyrsa
Solution for IV infusion
Also known as: Oritavancin
Solution for IV infusion
Also known as: Oritavancin
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 28
All-cause Mortality
Time frame: Day 28
Number of Participants with a Clinical Response of Cure or Failure
Time frame: Day 14 and Day 28
Area Under the Curve of Plasma Concentration (AUC) of Oritavancin
Time frame: Day 1 (up to 168 hours after start of infusion)
Maximal Plasma Concentration (Cmax) of Oritavancin
Time frame: Day 1 (up to 168 hours after start of infusion)
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Melinta Therapeutics, LLC