Who is sponsoring SOLO II?

SOLO II is sponsored by Melinta Therapeutics, Inc..

What condition does SOLO II study?

SOLO II studies Wound Infection, Abscess, Systemic Inflammation, Cellulitis.

What drugs are being tested in SOLO II?

Interventions: Single-Dose IV Oritavancin Diphosphate, IV Vancomycin.

What is the status of SOLO II?

SOLO II is currently COMPLETED.

Last reviewed 2021-04-12 · How we verify

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)

NCT01252732 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Melinta Therapeutics, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	1019
Start date	2010-12
Completion	2013-06

Conditions

Wound Infection
Abscess
Systemic Inflammation
Cellulitis

Interventions

Single-Dose IV Oritavancin Diphosphate
IV Vancomycin

Primary outcomes

Early Clinical Response — 48-72 hours after the initation of study therapy
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.

Countries

United States