Telithroniycin (HMR 3647) is a new ketolide antimicrobial that was developed for the treatment ofcommunityacquired respiratory tract infections. We conducted a randomized, double-blind, multicenter study to compare the clinical efficacy and safety of oral telithromycin; at 800 mg once dail yfor 5 or 10 days, with that ofamoxicillin/ clavulanic acid, at 500/125 mg three times daily for 10 days, in adults with acute maxillary sinusitis (AMS). A total of 754 patients with AMS of less than 28 days' duration were randomized to receive either telithromycin for 5 days follow ed by pla cebo for 5 days, telithromycin fo r 10 days, or amoxicillin/clavulanic acidfor 10 days. Clinical out com e was assessed at a test-of-cure (TOC) visit between days 17 and 24 and at a late post-therapy visit between days 31 and 45. Analysis ofclinical outcome on a per-protocol basis (n =434) demonstrated therapeutic equivalence among the three regimens at the TOC visit; in each treatment group , the clini cal cure rate was approximately 75%. Only a few patients (3 to 5 in each group) had relapsed by the late post-therapy follow-up visit. Telith romycin was generally saf e and well tolerated. The most common adverse events were mild or moderate gastrointestinal effects, which occurred with similarfrequency in all three group s. We conclude that 5 or 10 days of telithromycin at 800 mg once daily is as effective clinically and as well tolerated as 10 days of

Adult patients with acute sinusitis (n = 236) were randomized in a double-blind study to levofloxacin 500 mg orally once daily (n = 119) or clarithromycin 500 mg orally twice daily (n = 117) for 10-14 days. Between 2 and 5 days after therapy participants were evaluated as cured (no symptoms), improved (symptoms improved, no further therapy required), or failed (further therapy required). Clinical response rates (cured plus improved) for clinically evaluable patients were 93.9% for levofloxacin (n = 98) and 93.5% for clarithromycin (n = 93). The proportion of patients evaluated as cured was higher in the levofloxacin (40.8%) than in the clarithromycin arm (29.0%) and individual symptoms showed higher rates of resolution. Of patients receiving levofloxacin and clarithromycin, 22.5% and 39.3%, respectively, experienced adverse events related or possibly related to the study therapy. This study showed that, in the treatment of acute sinusitis, daily levofloxacin therapy is as effective as twice-daily clarithromycin therapy with more complete clearing of symptoms and a more tolerable side-effect profile.