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Early response to oritavancin predicted cure of bacterial skin infections
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WASHINGTON, D.C. — An early positive clinical response to oritavancin within 48 to 72 hours was highly predictive of an eventual cure in adult patients with acute bacterial skin and skin structure infections, according to recent data presented at ICAAC 2014.
Conversely, lack of an early clinical response to the antibiotic was not predictive of a cure, researchers said.
“A single dose of oritavancin is effective at treating acute bacterial skin and skin structure infections (ABSSSIs),” presenter Ralph Corey, MD, professor of medicine and infectious disease at Duke University, told Infectious Disease News. “It works.”
Ralph Corey
Corey and colleagues examined data from the phase 3 SOLO trials — randomized, double blind studies that compared a single dose of IV oritavancin (Orbactiv, The Medicines Company) with a 7- to 10-day course of IV vancomycin in the treatment of adults with ABSSSIs. The primary endpoints of the studies included an early clinical response at 48 to 72 hours, measured in part by a reduction in the size of a lesion, and the assessment of a clinical cure 7 to 14 days after the end of treatment.
A total of 1,626 patients enrolled in the trials were clinically evaluable. The positive predictive value of an early clinical response in the prediction of cure at 7 to 14 days after the end of therapy was approximately 95%. However, the negative predictive value of an early clinical response was approximately 20%, which the researchers attributed to the continued healing of the infection.
Oritavancin was approved by the FDA in August. The drug was designated as a qualified infectious disease product, which is granted to antibacterial or antifungal agents intended to treat serious or life-threatening infections.
Corey said a single-dose antibiotic such as oritavancin is a significant benefit to patients. Because the drug is a “concentration-dependent killer” with an extended half-life, infusion of a single large dose results in extremely rapid killing of the targeted bacteria, such as MRSA.
“The higher the concentration of the drug, the faster it kills the bacteria,” he said.
With these results, researchers must look at how to treat more serious infections, such as bloodstream infections, pneumonia and bone and joint infections, Corey said. — by John Schoen
For more information:
Corey R. Abstract F 972. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.
Disclosure: The SOLO trials were funded by The Medicines Company.