Study Demonstrates Clinical Efficacy of Telithromycin for Treatment of Mild to Moderate CAP

SAN DIEGO -- Data presented today at the annual International Conference of the American Thoracic Society in San Diego, from the Community-acquired pneumonia Outcome in high Bacterial Resistance Areas (COBRA) study, a randomized clinical superiority trial, showed that the clinical efficacy of telithromycin (marketed as KETEK) in outpatients with CAP is superior to that of local standard first line oral antibiotic therapy in areas with a high prevalence of penicillin or macrolide-resistant Streptococcus pneumoniae.  The clinical cure rate with telithromycin was 7.2 percent higher than the overall clinical cure rate with comparator antibiotics.

The clinical cure rates achieved in this study support the use of telithromycin as first line oral therapy for patients with (mild to moderate) community-acquired pneumonia and therefore may have important implications for decision making in everyday clinical practice, says professor C. Mayaud from the Service de Pneumologie/ Réanimation Respiratoire of Hôpital Tenon in Paris. Even if this study was not powered to show significant differences by patient sub-group, comparator sub-groups, or causative pathogen, it may signal that there are clinical benefits in treating CAP with an antibiotic that is active against both antibiotic-resistant pneumococci and atypical pathogens.

The COBRA study is a Phase IV clinical trial designed to compare the efficacy and safety of telithromycin to other standard, single agent antibiotics, such as cephalosporins, macrolides, and quinolones, in outpatients with mild to moderate CAP in areas with a high prevalence of penicillin and erythromycin-resistant S. pneumoniae isolates (erythromycin resistance rate >30 percent). The study enrolled 505 patients from Italy, Spain, Taiwan, Korea, Hong Kong, Hungary, Thailand, South Africa, Singapore, Tunisia, and Greece, and was completed in June 2004.

Outpatients with clinical and radiological evidence of CAP were centrally randomized to receive either telithromycin 800 mg for seven to 10 days or other standard first line oral antibiotic therapy (chosen by investigators in line with local treatment guidelines).  Clinical efficacy was assessed by the investigators post-therapy (days 17-21) and reviewed by three independent experts blinded to treatment groups.  Clinical failure was defined as subsequent antibiotic treatment for lower respiratory tract infection or CAP-related fever post-therapy.

A total of 505 patients were enrolled; 482 were included in the modified intent to treat (mITT) efficacy analysis. In the subgroup of patients with documented pneumococcal CAP, clinical cure rates were 90.7 percent (39/43) for TEL vs. 76.3 percent (39/51) for CMP.  Both treatments were similarly well tolerated.

Pneumonia is the leading infectious disease cause of death in the elderly and remains one of the top five causes of mortality in persons 65 of age and older. In the U.S. alone, there are between 2 to 3 million cases of CAP every year resulting in approximately 10 million physician visits, 500,000 hospitalizations and 45,000 deaths.  The overall cost for treating patients with CAP is more than $23 billion per year.  Patient compliance with antibiotic regimens is poor within the community; decreasing the frequency and duration of dosing may improve compliance.

Source: Sanofi-aventis Group