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Title: High Rate of Methicillin-Resistant Staphylococcus Infection Seen in Dalbavancin Phase 3 Trials: Presented at IDSA

"High Rate of Methicillin-Resistant Staphylococcus Infection Seen in Dalbavancin Phase 3 Trials: Presented at IDSA"

By Ed Susman SAN FRANCISCO, CA -- October 11, 2005 -- Methicillin resistance occurred in almost half of all patients with Staphylococcus aureus who were treated for skin and skin structure infections in phase 3 studies of a new antibiotic aimed at controlling resistant bacteria. In the studies, more than 90% of the pathogens were eradicated by treatment with dalbavancin, a lipogylcopeptide antibiotic derived by chemical modification of a teicoplanin-like molecule, reported Beth Goldstein, PhD, director of clinical microbiology, Vicuron Pharmaceuticals, King of Prussia, Pennsylvania. Vicuron funded the studies. About 80% of all the baseline isolates in 3 phase 3 studies of dalbavancin were identified as S. aureus. Of these 827 S. aureus isolates, 423 (49%) were identified as being methicillin-resistant isolates (MRSA), she said on October 7[^th at the 43^rd Annual Meeting of the Infectious Diseases Society of America (IDSA).

In 2 of the studies in which it was compared with either linezolid or vancomycin, dalbavancin demonstrated high rates of efficacy against MRSA. In 1 trial, MRSA was eradicated in 91.1% of patients taking dalbavancin compared with 89.0% of those on linezolid, and in 90.5% of patients taking dalbavancin compared with 81.8% of patients on vancomycin. Those differences did not reach statistical significance.

"Vancomycin appeared to have a somewhat lower percent of success," Dr. Goldstein noted, "however numbers were small, in part due to a higher proportion of patients not completing the study in the vancomycin arm."

Dr. Goldstein said the success in those studies shows that dalbavancin was clinically and microbiologically effective against skin and skin structure infections in humans.

"S. aureus was by far the most common organism associated with skin and soft tissue infections in these phase 3 studies of dalbavancin," Dr. Goldstein said in her poster presentation.

Two of the studies specifically looked at MRSA efficacy, while a third study attempted to exclude patients with MRSA infections, although a number of patients in that study were found to have MRSA and those figures were included in the studies of all persons with MRSA infection.

In the 2 studies that looked at all comers with the skin infections, more than 60% of the S. aureus infections were identified as being MRSA.

[Presentation title: Frequency of MRSA and Microbiological Efficacy in the Dalbavancin Phase 3 Skin and Skin Structure Program. Abstract 363]

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