Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin… (NCT01252732) | Clinical Trial Compass
CompletedPhase 3
Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
United States1,019 participantsStarted 2010-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females ≥18 years old
✓. Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy
✓. An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess
✓. ABSSSI must present with at least 2 signs and symptoms
✓. Able to give informed consent and willing to comply with all required study procedures
Exclusion criteria
✕. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days
✕. Infections associated with, or in close proximity to, a prosthetic device
✕. Severe sepsis or refractory shock
✕. Known or suspected bacteremia at time of screening
✕. ABSSSI due to or associated with any of the following:
✕. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
✕. Currently receiving chronic systemic immunosuppressive therapy
✕
What they're measuring
1
Early Clinical Response
Timeframe: 48-72 hours after the initation of study therapy