Multicenter, open-label, randomized study to compare the safety and efficacy of levofloxacin versus ceftriaxone sodium and erythromycin followed by clarithromycin and amoxicillin-clavulanate in the treatment of serious community-acquired pneumonia in adults

This randomized, multicenter, phase IV, comparative trial, which was designed to show equivalence, compared the efficacy of levofloxacin with that of a beta-lactam-macrolide combination in the treatment of 269 seriously ill patients with community-acquired pneumonia. Patients were randomly assigned to 1 of 2 treatment arms: (1) levofloxacin, 500 mg intravenously, followed by oral administration, every 24 h for 7-14 days, or (2) ceftriaxone sodium, 1-2 g intravenously or intramuscularly every 24 h, with erythromycin, 500-1000 mg intravenously every 6 h, and then switched to amoxicillin-clavulanate, 875 mg orally twice daily, with clarithromycin, 500 mg orally twice daily for 7-14 days. Among patients evaluable for clinical efficacy, 89.5% of levofloxacin-treated patients (85 of 95 patients) and 83.1% of comparator-treated patients (74 of 89 patients) achieved clinical success (a cure or an improved condition). Both levofloxacin and the comparator were safe and well tolerated, with gastrointestinal disorders being the most common adverse event in both groups. Levofloxacin was as efficacious as the beta-lactam-macrolide combination in the treatment of seriously ill patients with community-acquired pneumonia.