A single dose of oritavancin was noninferior to a regimen of twice-daily vancomycin given for 7 to 10 days in treating acute bacterial skin infections, according to data from the SOLO I trial.
Oritavancin, a lipoglycopeptide, also was noninferior to vancomycin in the treatment of MRSA, according to the report in The New England Journal of Medicine.
“The oritavancin regimen may ensure adherence to treatment, reduce or eliminate hospital stays and reduce the utilization of health care resources,” the researchers wrote. “[These results] should provide an impetus to determine the costs of outpatient care for patients with acute bacterial skin and skin-structure infections.”
Patients with acute bacterial skin and skin-structure infections (ABSSSIs) were randomly assigned to a single dose of 1,200 mg IV oritavancin (The Medicines Company) or to a regimen of IV vancomycin given twice daily for 7 to 10 days. The intention-to-treat analysis included 475 patients who received oritavancin and 479 patients who received vancomycin. The primary efficacy endpoint for noninferiority included non-increasing or reduction in lesion size, absence of fever and having no need to administer rescue antibiotics after oritavancin.
Oritavancin was noninferior to vancomycin in the primary efficacy endpoint: 82.3% for oritavancin vs. 78.9% for vancomycin. In the two secondary efficacy endpoints, oritavancin was noninferior to vancomycin in the rate of investigator-assessed clinical cure (79.6% vs. 80%) and in the proportion of patients whose lesions reduced by 20% or more (86.9% vs. 82.9%). The number of adverse events was similar for the two groups, but nausea was more common in the oritavancin group.
“Currently available therapeutic options for the treatment of acute bacterial skin and skin-structure infections require repeat administrations that may result in extended hospitalization and can result in substantial costs to the health care system,” the researchers wrote. “A single-dose treatment that results in an early and sustained clinical response could have the potential to reduce the complications associated with multiple intravenous administrations in patients with these infections, improve adherence to treatment [and] improve quality of life.”
Disclosure: The researchers report various relationships with Cempra, Cerexa, Cubist, DRL, GlaxoSmithKline, The Medicines Company, Merck, Pfizer, Seachaid Pharmaceuticals, Theravance, TMCo and Trius.