Comparison of hospitalization rates in patients with community-acquired pneumonia treated with 10 days of telithromycin or clarithromycin.
OBJECTIVE
To compare the impact on hospitalization rates and the clinical efficacy of oral telithromycin and clarithromycin treatment in patients with community-acquired pneumonia (CAP).


METHODS
Outpatients aged >or= 18 years (n = 448) with CAP were enrolled in a randomized, double-blind, multinational study and received telithromycin 800 mg once daily (n = 224) or clarithromycin 500 mg twice daily (n = 224) for 10 days. The primary outcome measure was clinical efficacy at post-therapy/test of cure (Days 17-24) in the per-protocol population. Frequency of CAP-related hospitalizations, physician visits/tests/procedures, and additional respiratory tract infection-related antibacterial use were compared by treatment group (intent to treat population) up to the late post-therapy visit (Days 31-36). Study investigators who were blinded to the treatment arm assessed whether hospital admissions were CAP related or not. Hospitalization costs (USdollars) associated with telithromycin and clarithromycin treatment were compared.


RESULTS
Per-protocol clinical cure rates for telithromycin and clarithromycin were statistically reduced number of hospitalizations/days required equivalent (88.3% [143/162] vs 88.5% [138/156] - difference: -0.2%; 95% CI: -7.8, 7.5). There were four CAP-related hospitalizations (1.8 events/100 patients) among patients treated with telithromycin vs eight (3.6 events/100 patients) among clarithromycin patients (p = 0.281). Total CAP-related hospitalization costs for telithromycin and clarithromycin patients were $25 360 vs $70 567, respectively (difference: -20 182 per 100 patients; 95% CI: -49 531; 9168) [corrected].


CONCLUSIONS
This study demonstrates that telithromycin is an effective therapy for outpatients with CAP. There were no significant differences in hospitalization rates between treatments; however, a tendency towards a numerically in hospital among telithromycin patients was observed. This could potentially translate into reduced hospitalization costs for telithromycin vs clarithromycin in the treatment of CAP.
Niederman
Michael S
MS
Winthrop-University Hospital, Minneola, NY 11501, USA. mniederman@winthrop.org
Chang
Joanne R
JR
Stewart
John
J
Nusrat
Roomi
R
Nieman
Richard B
RB
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D048628:Ketolides; D018942:Macrolides / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D048628:Ketolides; D018942:Macrolides; D017291:Clarithromycin; C106791:telithromycin