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Once-Daily Telithromycin Proves Safe, Effective for Community-Acquired Respiratory Infections: Presented at ICAAC

By Michael Smith

SAN DIEGO, CA -- October 3, 2002 -- A head-to-head study involving 24,000 patients has shown that once-daily telithromycin is as safe and effective as twice-daily amoxicillin-clavulanate (AMC) in the treatment of community-acquired upper respiratory tract infections.

Such infections are among the most frequently seen in outpatients, said Dr. Paul Iannini, MD, of Danbury Hospital, Danbury, Connecticut, in a presentation here at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). If left untreated, he said, they can cause significant mortality.

Telithromycin, a ketolide, is the first member of a new class of antibacterial agents developed to treat such infections; it has a broad spectrum, is active against bacteria resistant to other agents, and can be given once-daily, thus potentially improving compliance.

The goal of the study was to assess the safety and efficacy of telithromycin in a range of upper respiratory infections, including pneumonia, acute sinusitis, and acute exacerbation of chronic bronchitis, in a usual-care setting. Amoxicillin-clavulanate was chosen as the comparator because its safety and efficacy profiles are well known, Dr. Iannini said.

Patients were randomised on their first visit and evaluated on their second visit (day 17 to 22) and on their third (day 30 to 35). In both arms, 8.9 percent of patients presented with pneumonia, 31 percent with acute exacerbation of bronchitis, and 60 percent with acute sinusitis.

The safety profile for the two arms was similar. Most treatment-emergent adverse effects were mild and transient; the most common were gastrointestinal disorders. The incidence of serious adverse events was 1.3 percent in the telithromycin group and 1.1 percent for AMC.

The efficacy profiles were also similar. The hospitalisation rate at the second visit for telithromycin was 1.1 percent, compared to 0.97 percent for AMC; on the third visit, the rates were 0.75 and 0.66, respectively.

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