Jim Kling

September 13, 2013

DENVER — For acute bacterial and structural skin infections that require intravenous therapy, a single dose of oritavancin is as effective as a 7- to 10-day dose of vancomycin, according to new research.

It is also effective against methicillin-resistant Staphylococcus aureus (MRSA).

The convenience of oritavancin could be an attractive option for patients. They would not have to be admitted to the hospital or endure a week or more of IV infusions. "They could get 1 infusion for 3 hours and then get sent home. Which would you choose?" said Ralph Corey, MD, professor of medicine and pathology at the Duke Clinical Research Institute in Durham, North Carolina.

Dr. Corey presented the findings here at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy.

Reducing exposure to IV catheters could also reduce the risk for infection. "There aren't a lot of complications associated with IV catheters, but they aren't benign," Dr. Corey told Medscape Medical News.

 
It could make a major difference in how we treat patients.
 

Oritavancin is an investigational lipoglycopeptide being developed by The Medicines Company. It has a long half-life and rapid bactericidal activity against Gram-positive bacteria, including MRSA. These properties make it a candidate for single-dose administration.

Dr. Corey and his team randomized adults with acute bacterial and structure skin infections who required IV therapy to a single 1200 mg dose of oritavancin or to vancomycin for 7 to 10 days.

The primary efficacy end point was assessed 48 to 72 hours after the oritavancin dose or first vancomycin dose. The researchers defined efficacy as the cessation of spread or reduction in size of the baseline lesion, the absence of fever, and no requirement for rescue antibiotics.

They conducted a separate analysis of patients whose infections were caused by MRSA. Efficacy outcomes were similar for all groups.

Table. Efficacy for Acute Bacterial and Structural Skin Infections

Outcome Oritavancin Vancomycin
All patients n = 475 n = 479
Primary end point reached 82.3% 78.9%
≥20% reduction in lesion area at 48–72 h 86.9% 82.9%
Investigator-assessed cure 7-14 d post-treatment 79.6% 80.0%
MRSA-infected patients n = 104 n = 100
Primary end point reached 80.8% 80.0%
≥20% reduction in lesion area at 48–72 h 90.4% 84.0%
Investigator-assessed cure 7-14 d post-treatment 82.7% 83.0%

 

Rates of adverse events were similar in the 2 group; 60.0% of the oritavancin group reported at least 1 adverse event, as did 63.8% of the vancomycin group.

There were fewer treatment-emergent adverse events with oritavancin than with vancomycin (22.8% vs 31.4%; P = .003). There were also fewer skin and subcutaneous adverse events with oritavancin (11.6% vs 19.1%; P = .001).

The similar safety profiles in the 2 groups were a relief to Dr. Corey. "We were really worried about safety. What happens if you have reaction to the drug and it's still in the body 2 months later? But the safety data were really nice."

The results are potentially practice-changing, Steven Weisholtz, MD, chief of infectious disease at Englewood Hospital Medical Center in New Jersey, told Medscape Medical News. "If we have a patient who ordinarily might need to be admitted, we could give them a single dose in the emergency room and send them home, or at least discharge them a lot quicker. It could make a major difference in how we treat patients."

Dr. Corey reports working with The Medicines Company, Pfizer, Merck, Achaogen, Cubist, Forest, Cerexa, Cempra, Theravance, Trius, and GlaxoSmithKline. Dr. Weisholtz has disclosed no relevant financial relationships.

53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): Abstract L-204. Presented September 10, 2013.

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