Community-Acquired Pneumonia Recovery in the Elderly (CAPRIE): Efficacy and Safety of Moxifloxacin Therapy versus That of Levofloxacin Therapy

Background. Limited prospective data are available for elderly patients with community-acquired pneumonia (CAP). This study aimed to determine the efficacy and safety of moxifloxacin versus that of levofloxacin for the treatment of CAP in hospitalized elderly patients (age, 65 years). Methods. We conducted a prospective, double-blind, randomized, controlled trial. Eligible patients were strat-ified by CAP severity before randomization to receive treatment with either intravenous/oral moxifloxacin (400 mg daily) or intravenous/oral levofloxacin (500 mg daily) for 7–14 days. Clinical response at test-of-cure (the primary efficacy end point was between days 5 and 21 after completion of therapy), and clinical response during therapy (between days 3 and 5 after the start of therapy) and bacteriologic response were secondary end points. Results. The safety population included 394 patients (195 in the moxifloxacin group and 199 in the levofloxacin group). The population eligible for clinical efficacy analysis (i.e., the clinically valid population) included 281 patients (141 in the moxifloxacin group and 140 in the levofloxacin group); 51.3 % were male, and the mean age (SD) was years. Cure rates at test-of-cure for the clinically valid population were 92.9 % in the77.4 7.7 moxifloxacin arm and 87.9 % in the levofloxacin arm (95 % confidence interval [CI],1.9 to 11.9;). ClinicalPp.2 recovery by days 3–5 after the start of treatment was 97.9 % in the moxifloxacin arm vs. 90.0 % in the levofloxaci