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AAAAI: Ketek (Telithromycin) Shows Activity in Acute Maxillary Sinusitis Caused By Drug Resistant Bacteria NEW YORK, NY -- March 5, 2002 -- Clinical trial results presented today at the 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) found that Ketek™ (telithromycin) is active in patients with Acute Maxillary Sinusitis (AMS). The results showed that Ketek 800 mg once daily for five days achieved high clinical cure and eradication rates in patients with infections caused by drug-resistant Streptococcus pneumoniae. According to the National Foundation for Infectious Diseases, between 3 percent and 35 percent of all pneumococcal illness is due to drug-resistant strains. "These results show Ketek provides activity in a once-daily, short-duration regimen for patients with drug-resistant AMS," said Patricia P. Buchanan, M.D., lead investigator, president of River Road Medical Group, director of Willamette Valley Clinical Studies, Eugene, Oregon. The Phase III, multicenter, double-blind study was conducted on adult and adolescent patients with clinical signs and symptoms of AMS. A total of 252 patients were treated with Ketek. Of those patients, 27 had S. pneumoniae isolates with an eradication rate of 88.9 percent, and 14 patients had pre-treatment isolates resistant to penicillin G (MIC>2.0 mg/L) and/or erythromycin A (MIC>1.0 mg/L). In these patients with resistance microorganisms, a total of 93 percent of isolates were susceptible to Ketek (MICs< 0.5 mg/L) and 85.7 percent achieved satisfactory clinical and bacteriological outcomes. To date, telithromycin has been examined in nine randomised, double-blind, comparator-controlled clinical trials. The most common adverse events reported included diarrhea, nausea, dizziness and vomiting. The majority of adverse events were mild to moderate in intensity. In June 2001, Aventis Pharmaceuticals received an approvable letter from the U.S. Food and Drug Administration (FDA) for the use of telithromycin for the following indications: community-acquired pneumonia (CAP), acute bacterial exacerbations of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS). The FDA said the drug was not approvable for the treatment of tonsillitis/pharyngitis. SOURCE: Aventis Pharmaceuticals E-mail this page to a friend or colleague! To print, use this version