Abstract: | SUMMARYAims: To compare the impact on hospitalization rates and the clinical efficacy of oral telithromycin and clarithromycin treatment in patients with community-acquired pneumonia (CAP).Patients and methods: Outpatients aged >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 (US$) associated with telithromycin and clarithromycin treatment were compared.Results: Per-protocol clinical cure rates for telithromycin and clarithromycin were statistically 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). The total number of CAP-related hospital days for telithromycin and clarithromycin patients was 23 vs 64 days (10.3 vs 28.6 days/100 patients), respectively (p?=?0.177). CAP-related hospitalization costs per 100 telithromycin and clarithromycin patients were $20360 vs $70567, respectively (difference: ?25182; 95% CI: ?49531; 9168).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 reduced number of hospitalizations/days required in hospital among telithromycin patients was observed. This could potentially translate into reduced hospitalization costs for telithromycin vs clarithromycin in the treatment of CAP. |