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Single-dose Oritavancin Compared to 7-10 days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections; the SOLO II Non-inferiority Study.
Clin Infect Dis. 2014 Oct 6;
Authors: Corey GR, Good S, Jiang H, Moeck G, Wikler M, Green S, Manos P, Keech R, Singh R, Heller B, Bubnova N, O'Riordan W, for the SOLO II Investigators
Abstract
BACKGROUND: Oritavancin is a lipoglycopeptide antibiotic with rapid bactericidal activity against gram-positive bacteria. Its concentration dependent activity and long half-life allow for single-dose treatment.
METHODS: In a randomized, double-blind trial, adults with acute bacterial skin and skin structure infections received either a single IV 1200 mg dose of oritavancin or 7 to 10 days of twice-daily vancomycin. Three efficacy endpoints were tested for non-inferiority: 1) primary composite endpoint at 48 to 72 hours (cessation of spreading or reduction in lesion size, absence of fever, and no rescue antibiotic); 2) investigator-assessed clinical cure 7 to 14 days after end of treatment; and 3) ≥20% reduction in lesion area at 48 to 72 hours.
RESULTS: A total of 503 and 502 patients comprised the modified intent to treat (mITT) population for oritavancin and vancomycin, respectively. All three efficacy endpoints met the 10% non-inferiority margin: the primary composite endpoint, 80.1% vs 82.9%; [95% confidence interval (CI): -7.5, 2.0], investigator-assessed clinical cure, 82.7% vs 80.5%, [CI: -2.6, 7.0] and proportion of patients attaining ≥20% reduction in lesion area, 85.9% vs 85.3%, [CI: -3.7, 5.0] for oritavancin vs vancomycin respectively. Efficacy outcomes by pathogen, including methicillin-resistant Staphylococcus aureus and the frequency of adverse events were similar between treatment groups.
CONCLUSIONS: A single 1200 mg dose of oritavancin was non-inferior to 7 to 10 days of vancomycin in treating ABSSSI caused by gram-positive pathogens, and was well tolerated. Oritavancin provides a single-dose alternative to multi-dose therapies for the treatment of ABSSSI. Trial registration. ClinicalTrials.gov identifier: NCT01252732.
PMID: 25294250 [PubMed - as supplied by publisher]