Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and … (NCT01252719) | Clinical Trial Compass
CompletedPhase 3
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
United States968 participantsStarted 2010-12
Plain-language 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.
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 7 days of IV therapy
✓. An ABSSSI included 1 of the following infections: wound infections, cellulitis/erysipelas, major cutaneous abscess
✓. ABSSSI must have presented with at least 2 local signs and symptoms and at least 1 sign of systemic inflammation (unless \>70 years of age).
✓. 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 unless:
✕. 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 participant with suspected or proven polymicrobial wound infection involving gram-negative and/or anaerobic bacteria
✕. Was currently receiving chronic systemic immunosuppressive therapy
What they're measuring
1
Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours)
Timeframe: 48-72 hours after the initiation of study therapy