CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,019 enrolled
Drug / intervention
Single-Dose IV Oritavancin Diphosphate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01252732
NCT01252732Phase 3Completed
CompareCT.gov

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 II)

Melinta Therapeutics, Inc.·interventional·Posted Dec 3, 2010·Updated May 5, 2021

In Brief

A Phase 3 clinical trial evaluating Single-Dose IV Oritavancin Diphosphate and IV Vancomycin for Wound Infection and 3 related conditions. Completed, enrolled 1,019 participants across 1 site.

Detailed Summary

The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Infection, Abscess, Systemic Inflammation, Cellulitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2010
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.6 years ago

Interventions

Single-Dose IV Oritavancin Diphosphatedrug

Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

IV Vancomycindrug

Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.