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NCT01252719 · ClinicalTrials.gov registry record · Phase 3
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
A Phase 3 study of Abscess and Cellulitis, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 968
- Enrollment target
- 1
- Study location
NCT01252719: Completed Phase 3 study of Abscess and Cellulitis, sponsored by Melinta Therapeutics.
NCT01252719 is a Phase 3 study of Abscess and Cellulitis that has completed, run by Melinta Therapeutics. The registered enrollment target is 968 participants, above the 315-participant average among 13 other Abscess trials with a reported enrollment target (207% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01252719, a Phase 3 study of Abscess and Cellulitis, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 968 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.
Primary Outcome
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication. A participant was classified as "success" if all of the following were met: cessation of spread or reduction of the lesion (defined as cessation of spread of the redness, edema, and/or induration or reduction
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Single-Dose IV Oritavancin Diphosphate
- DRUG IV Vancomycin
Study Locations (1)
California
- Sharp Chula Vista Medical Center - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 968 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-11-30 |
| Phase | Phase 3 |
What the finished NCT01252719 record still lists
NCT01252719 is an interventional study that assigns participants to a tested intervention. The registered 968 participants enrollment target is mid-sized for trials with a published cap, above the 315-participant average among 13 other Abscess trials with a reported enrollment target (207% higher).
The record links to 4 conditions, with Abscess appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01252719 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01252719 about?
NCT01252719 is a clinical study titled "Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)". The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of ori...
What is the current status of trial NCT01252719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 968 participants. The study started on 2010-12. Estimated completion is 2012-11-30.
What conditions does trial NCT01252719 study?
This clinical trial studies the following conditions: Abscess, Cellulitis, Wound Infection, Systemic Inflammation.
What interventions are being tested in trial NCT01252719?
The interventions under investigation include: Placebo (DRUG), Single-Dose IV Oritavancin Diphosphate (DRUG), IV Vancomycin (DRUG).
Who is sponsoring clinical trial NCT01252719?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01252719 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Abscess
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01252719's enrollment target sits among peer trials
968 3rd of 13 higher than 11 of 13 other Abscess trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abscess 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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