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
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]