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| |  ICAAC: Ketek (Telithromycin) Active in Treating Community-acquired Pneumonia Caused by Streptococcus pneumoniae CHICAGO, IL -- December 17, 2001 -- Clinical trial results presented at the 41st annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) found that Ketek shows activity in the treatment of community-acquired pneumonia (CAP) caused by drug-resistant and non-resistant Streptococcus pneumoniae as well as atypical or intracellular pathogens, including Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumophila. Study results also found that Ketek shows activity in the treatment of pneumococcal bacteraemia, a serious blood-stream infection that can result as a complication of CAP. Annually, two to three million cases of CAP result in nearly 10 million physician visits, 500,000 hospitalisations and 45,000 deaths in the United States, according to the Infectious Disease Society of America (IDSA). "The high clinical cure rate achieved in these clinical studies suggests that telithromycin would be a valuable addition to the currently available antibiotic armamentarium," said Thomas File, MD, professor of internal medicine, Northeastern Ohio Universities College of Medicine. A total of 432 patients from North America, South America and South Africa with documented cases of CAP received oral telithromycin 800 mg once daily for seven days in an open-label clinical trial. The clinical cure rate was 93 percent in the per-protocol population. Telithromycin exhibited satisfactory bacteriologic and clinical outcomes in all of the 57 patients whose CAP was identified pre-study as being caused by S. pneumoniae, including nine patients with strains resistant to penicillin and/or erythromycin. In a comparison study that pooled the results of three Phase III double-blind trials of 1,024 adult CAP patients from South Africa, Sweden, France and the United States, 503 patients received telithromycin (800 mg, once daily) for seven to 10 days and the remaining patients received either amoxicillin (1,000 mg, three times daily) or clarithromycin (500 mg, twice daily) for 10 days or trovafloxacin (200 mg, once daily) for seven to 10 days. Study results showed that telithromycin was as active as all pooled comparators. Telithromycin was examined in 1,373 adult patients in six Phase III multi-centre studies in treating CAP caused by atypical or intracellular pathogens. Thirty-one of the 1,373 patients with CAP were confirmed to be caused by Mycoplasma pneumoniae and 97 percent of these achieved clinical cure rate with telithromycin. Among those 1,373 patients, 56 were determined to have pneumococcal bacteraemia, a bloodstream infection that can be a serious complication of community-acquired pneumonia, with a high mortality rate. Telithromycin successfully eradicated the bacteraemia in 92 percent of the confirmed cases. To date, the safety and tolerability of telithromycin was examined in nine randomised, double-blind, comparator-controlled clinical trials. The most common adverse events reported included diarrhoea, nausea, dizziness and vomiting. The majority of adverse events were mild to moderate in intensity. In June 2001, Aventis received a letter of approval from the US 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). SOURCE: Aventis Pharmaceuticals
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