Clinical evaluation of telithromycin for community-acquired pneumonia - Phase III double-blind comparative study of telithromycin versus levofloxacin

The clinical efficacy and safety of telithromycin (TEL), a new ketolide antibiotic, were evaluation in community-acquired pneumonia in a double-blind, randomized, drug-controlled, two-groups parallel-group, non-inferiority comparative study versus levofloxacin (LVFX). The dose and dosage of TEL was 600 mg once daily (TEL group) and those of LVFX was 100 mg 3 times daily (LVFX group). The treatment period was either 7 days. The following results were obtained in this trial. 1. Clinical efficacy. Two hundred seven patients were evaluated for clinical efficacy. The clinical efficacy rates against pneumonia were 93.6% (102/109) in TEL group and 87.8% (86/98) in LVFX group. The difference of clinical efficacy rate (TEL group - LVFX group) was 5.8% and its 2-sided 95% confidence interval was [-3.1, 14.7]. The lower limit of the confidence interval provided by the clinical trial protocol was not less than -15%, and so the fact that TEL is not inferior to LVFX was verified. 2. Bacteriological efficacy. The eradication rate excluding indeterminate 119 cases out of 205 cases for bacteriological efficacy analysis was respectively 73.9% (34/46) in TEL group and 100.0% (40/40) in LVFX group. Bacterial species not eradicated in TEL group was mainly Haemophilus influenzae, but clinical efficacy rates of TEL and LVFX against cases whose causative organism was this bacteria were respectively 96.8% (30/31) and 86.7% (13/15). In TEL group, resistant Streptococcus pneumoniae strains were all eradicated except for 1 strain of erythromycin-resistant S. pneumoniae. 3. Safety. Case number for the safety analysis was 244. The incidence rates of side effects excluding uncertain 4 cases were respectively 33.6% (42/125) in TEL group and 33.9% (39/115) in LVFX group. No significant difference was found between the groups with respect to the incidence rate of side effects. Considering from above results, it was suggested that 600 mg TEL administered once a day for 7 days could be expected to be clinically very useful in the treatment of community-acquired pneumonia.