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Trial Shows Single-Dose Antibiotic Effective with MRSA

MRSA bacteria (CDC)

Scanning electron micrograph image of MRSA bacteria (Janice Haney Carr, Centers for Disease Control and Prevention)

5 June 2014. Researchers at Duke University in Durham, North Carolina and the Medicines Company in Parsippany, New Jersey show in a late-stage clinical trial that a single dose of the antibiotic oritavancin works as well in treating acute bacterial skin infections, including those from methicillin-resistant Staphylococcus aureus (MRSA) bacteria, as the current standard of care requiring infusions for up to 10 days. The team led by Duke’s Ralph Corey that includes members from medical centers in the U.S. and India, published its findings in today’s issue of the New England Journal of Medicine (paid subscription required).

The Medicines Company cites data indicating some 5.2 million people in the U.S. and Europe are hospitalized with acute bacterial skin infections each year. MRSA bacteria are also skin infections, resistant to many antibiotics, and a particular problem in health care facilities. While the number of hospital-acquired MRSA cases declined over the past few years, it remains an important public health problem.

The clinical trial tested the new antibiotic oritavancin, made by Medicines Company, against the current drug vancomycin used to treat acute bacterial skin infections. Both drugs are given intravenously. Oritavancin, however, requires only a single dose of 1,200 milligrams, while vancomycin is given twice a day for 7 to 10 days at a time. Oritavancin has a protein chemistry giving it a longer effective working life in the body, thus needing only a single dose.

In the study, 954 patients with serious skin infections, including those with abscesses and inflammation, were enrolled at 46 sites worldwide. About half of the group randomly received the single dose of oritavancin, while the remainder received normal vancomycin treatments. The researchers looked primarily at the ability of the drugs to reduce the size of skin lesions and fever in the patients, within 48 to 72 hours after treatment.

Corey and colleagues report both oritavancin and vancomycin reduced the area of infections by about 20 percent within 48 to 72 hours, as well as lowered fever in the patients. Both antibiotics worked about as well in curing the infections overall after 7 to 14 days following treatment. In addition, the drugs had comparable results treating MRSA infections, as well as comparable numbers of adverse events.

Medicines Company conducted a similar trial — including tests of patients with MRSA — last year using a somewhat larger sample which, combined with the results of this trial, will be submitted to the U.S. Food and Drug Administration for approval. The company says FDA expects to complete its review of oritavancin by 6 August.

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