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| |  ICC: Ketek (Telithromycin) Highly Effective In Treatment Of Pneumococcal Bacteraemia Associated With Pneumonia AMSTERDAM, THE NETHERLANDS -- July 2 2001 -- Ketek (telithromycin), a novel compound from a new class of antibiotics, administered once daily for seven to 10 days, is a highly effective treatment for patients with pneumococcal bacteraemia associated with community-acquired pneumonia (CAP), according to a study reported today at a major scientific meeting. The study, presented today at the 22nd International Congress of Chemotherapy (ICC), in Amsterdam, The Netherlands, involved an analysis of data from Phase III studies of Ketek -- the first in a new class of antibiotics called ketolides. The efficacy of Ketek 800 mg once daily was assessed in 955 patients between the ages of 18 and 65 with signs, symptoms and radiological confirmation of CAP in five clinical trials. Blood samples were taken pre-therapy for aerobic and anaerobic culture. Clinical and bacteriological outcomes were assessed seven to 11 days after the treatment was finished. Forty-seven (4.9 percent) of the Ketek-treated patients with CAP had documented pneumococcal bacteraemia at baseline. The clinical cure rate was 89.5 percent, with a bacterial eradication rate post therapy of 89.5 percent. Bacteraemia occurs in up to 30 percent of patients with pneumococcal pneumonia and represents a significant factor for morbidity. Also presented today were the results of the safety and tolerability of Ketek in more than 1800 adults with community-acquired respiratory tract infections (CARTIs) in eight randomised, double-blind comparator-controlled studies. Patients received Ketek 800 mg once daily for five or seven to 10 days or a comparator (clarithromycin, amoxicillin, clavulanate, cefuroxime axetil or penicillin V [for 10 days] or trovafloxacin [seven to 10 days]). 677 (35.8 percent) of the Ketek-treated patients reported at least one treatment-emergent adverse event (TEAE) considered possibly related to the study treatment. The most commonly reported TEAEs were diarrhea, nausea, dizziness and vomiting. The majority of the events were mild or moderate in intensity, with few resulting in treatment discontinuations (4.0 percent). Ketek has been developed specifically to offer optimal coverage in upper and lower respiratory tract infections including those caused by resistant pathogens with a short and reliable once-daily regimen. In March of this year, Aventis received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP), the scientific body of the European Medicines Evaluation Agency (EMEA) recommending the granting of a marketing authorisation for Ketek for use in treating CAP, acute exacerbation of chronic bronchitis (AECB), acute sinusitis and tonsillitis/pharyngitis. Additionally, the U.S. Food and Drug Administration (FDA) recently granted an approvable letter for Ketek for CAP, acute bacterial exacerbation of chronic bronchitis (ABECB), and acute bacterial sinusitis (ABS). SOURCE: Aventis Pharma
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