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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: Completed Phase 2 study, sponsored by Melinta Therapeutics.
NCT05599295 is a Phase 2 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT05599295 record still lists
NCT05599295 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Orbactiv is the first listed.
NCT05599295 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05599295's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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