Trials / Completed
CompletedNCT01252719
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 968 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This was a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally. In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated the potential health economic benefits offered by this dosing strategy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Single-Dose IV Oritavancin Diphosphate | Oritavancin was administered as a single IV dose. |
| DRUG | IV Vancomycin | Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days. |
| DRUG | Placebo | Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo). |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-10-01
- Completion
- 2012-11-30
- First posted
- 2010-12-03
- Last updated
- 2022-08-01
- Results posted
- 2022-08-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01252719. Inclusion in this directory is not an endorsement.