This excerpt taken from the SNY 6-K filed Jun 1, 2005.
About the COBRA study
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 ß-lactams, 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 7-10 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 (Day 17-21) and reviewed by 3 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 comparators group (CMP), 39 percent of patients received macrolides, 44 percent ß-lactams, and 17 percent fluoroquinolones. Overall clinical cure rates in the telithromycin (TEL) group were significantly higher that those in the CMP group:
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 older1. It is generally recognized that S. pneumoniae is the most important causal bacterium in most countries2. In Europe, there are over 3 million cases of CAP annually with an estimated 23 million seen in the USA. Improvement in the outpatient management of CAP could result in significant benefit for the patients