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Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)

NCT01252719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 968

Last updated 2022-08-01

Study results available
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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.

Conditions

  • Wound Infection
  • Abscess
  • Systemic Inflammation
  • Cellulitis

Interventions

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).

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • G. Ralph Corey, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-10-31
Completion
2012-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01252719 on ClinicalTrials.gov