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NCT05599295 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
A Phase 2 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
NCT05599295 is a Phase 2 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 118 participants.
The verdict
NCT05599295, a Phase 2 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
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.
Interventions
- DRUG Orbactiv
- DRUG Kimyrsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2025-11-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05599295
The ClinicalTrials.gov registry entry for NCT05599295 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melinta Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Orbactiv is the first listed.
NCT05599295 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05599295 about?
NCT05599295 is a clinical study titled "Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections". 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...
What is the current status of trial NCT05599295?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2023-06-15. Estimated completion is 2025-11-20.
What interventions are being tested in trial NCT05599295?
The interventions under investigation include: Orbactiv (DRUG), Kimyrsa (DRUG).
Who is sponsoring clinical trial NCT05599295?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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