Single-Dose Oritavancin Versus 7–10 Days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study
| Autor: | Greg Moeck, Natalia Bubnova, Matthew A. Wikler, Richard Keech, G. Ralph Corey, Barry Heller, William O'Riordan, Rajesh P Singh, Samantha Good, Hai Jiang, Sinikka Green, Paul Manos |
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| Rok vydání: | 2014 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty education.field_of_study Lipoglycopeptide business.industry medicine.drug_class Antibiotics Oritavancin Population medicine.disease_cause Methicillin-resistant Staphylococcus aureus Surgery Lesion chemistry.chemical_compound Infectious Diseases chemistry Internal medicine medicine Vancomycin medicine.symptom business education Adverse effect medicine.drug |
| Zdroj: | Clinical Infectious Diseases. 60:254-262 |
| ISSN: | 1537-6591 1058-4838 |
| Popis: | 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 (ABSSSIs) received either a single intravenous 1200-mg dose of oritavancin or 7-10 days of twice-daily vancomycin. Three efficacy endpoints were tested for noninferiority: (1) primary composite endpoint at 48-72 hours (cessation of spreading or reduction in lesion size, absence of fever, and no rescue antibiotic); (2) investigator-assessed clinical cure 7-14 days after end of treatment; and (3) ≥20% reduction in lesion area at 48-72 hours. Results A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin, respectively. All 3 efficacy endpoints met the 10% noninferiority margin: the primary composite endpoint (80.1% vs 82.9%; 95% confidence interval [CI], -7.5 to 2.0), investigator-assessed clinical cure (82.7% vs 80.5%; 95% CI, -2.6 to 7.0), and proportion of patients attaining ≥20% reduction in lesion area (85.9% vs 85.3%; 95% CI, -3.7 to 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 noninferior to 7-10 days of vancomycin in treating ABSSSIs caused by gram-positive pathogens, and was well tolerated. Oritavancin provides a single-dose alternative to multidose therapies for the treatment of ABSSSIs. Clinical Trials Registration. NCT01252732. |
| Databáze: | OpenAIRE |
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