Clinical and bacteriological efficacy and safety of 5 and 7 day regimens of telithromycin once daily compared with a 10 day regimen of clarithromycin twice daily in patients with mild to moderate community-acquired pneumonia.
OBJECTIVE
This study was conducted to investigate the potential equivalence in clinical efficacy and assess safety of a 5 or 7 day regimen of oral telithromycin (800 mg once daily) and a 10 day regimen of oral clarithromycin (500 mg twice daily) in treating community-acquired pneumonia (CAP). Bacteriological efficacy was also compared.


METHODS
This was a multicentre, randomized, double-blind, active-controlled study. Patients with mild to moderate CAP received telithromycin 800 mg once a day for 5 (n=193) or 7 (n=195) days or clarithromycin 500 mg twice a day for 10 days (n=187). In these groups, 159, 161 and 146 patients, respectively, completed the study.


RESULTS
At the post-therapy/test-of-cure evaluation, clinical cure rates (per-protocol clinical population) were 89.3% (5 days) and 88.8% (7 days) for telithromycin, and 91.8% for clarithromycin 10 days. Satisfactory bacteriological outcome rates (per-protocol bacteriological population) were 87.7% and 80.0% for 5 and 7 days of telithromycin, respectively, and 83.3% for 10 days of clarithromycin. Bacteriological eradication rates in the respective treatment groups were, for Streptococcus pneumoniae, 95.8% (23/24), 96.7% (29/30) and 88.5% (23/26); for Haemophilus influenzae, 88.0% (22/25), 84.0% (21/25) and 88.2% (15/17) and for Moraxella catarrhalis, 1/1, 4/5 and 3/4. Both telithromycin regimens demonstrated clinical efficacy against pneumococcal bacteraemia (19/19), atypical pathogens (9/9) and erythromycin-resistant S. pneumoniae isolates (5/5). Most treatment-emergent adverse events were mild to moderate in intensity with most commonly reported adverse events involving the gastrointestinal system.


CONCLUSIONS
Telithromycin 800 mg administered once a day for 5 or 7 days was as effective and safe as clarithromycin 500 mg administered twice a day for 10 days in treating patients with CAP caused by common respiratory pathogens, including macrolide-resistant isolates, and pneumococcal bacteraemia.
Tellier
Guy
G
Zoom International Clinical Research Group, 290 Montigny Street, Saint-Jerome, Quebec J7Z 5T3, Canada. zoominternational.tellier@qc.aira.com
Niederman
Michael S
MS
Nusrat
Roomi
R
Patel
Manish
M
Lavin
Bruce
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage* / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D004562:Electrocardiography / Q000187:drug effects; D004790:Enzyme Induction / Q000187:drug effects; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D048628:Ketolides; D008111:Liver Function Tests; D018942:Macrolides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D001936:Moraxella catarrhalis / Q000187:drug effects; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology; D018401:Sample Size; D013183:Sputum / Q000382:microbiology; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D048628:Ketolides; D018942:Macrolides; D017291:Clarithromycin; C106791:telithromycin