Oral Moxifloxacin vs High-Dosage Amoxicillin in the Treatment of Mild-to-Moderate, Community-Acquired, Suspected Pneumococcal Pneumonia in Adults

Comparison of the efficacy andsafety of moxifloxacin vs amoxicillin for treatment ofmild-to-moderate, suspected pneumococcal community-acquired pneumonia(CAP) in adult patients. Multinational, multicenter, double-blind, randomized study. Eighty-two centers in 20 countries (Argentina, Brazil, Chile, Croatia, Czech Republic, Estonia, France, Hong Kong, Hungary, Lithuania, Mexico, Portugal, Russia, Slovenia, South Africa, Spain, Turkey, Ukraine, United Kingdom, and Uruguay). Four hundredeleven adults (inpatients or outpatients) with suspected pneumococcal, CAP. Randomization 1:1 tomoxifloxacin, 400 mg/d, or amoxicillin, 1,000 g tid, for 10 days. Primary efficacy parameter was clinicalresponse, 3 to 5 days after therapy (end of therapy [EOT]) in the perprotocol (PP) population (362 patients). The clinical success rate inthe PP population was 91.5% (moxifloxacin) and 89.7% (amoxicillin; two-sided 95% confidence interval, −4.2 to 7.8%). The clinical curerate in patients with proven pneumococcal pneumonia was similar in bothtreatment groups (87.8%). The bacteriologic success rate in 136bacteriologically evaluable patients at the EOT was 89.7%(moxifloxacin) and 82.4% (amoxicillin). The bacteriologic success rateagainst Streptococcus pneumoniae was 89.6%(moxifloxacin) and 84.8% (amoxicillin). The frequency of adverseevents was comparable in both treatment groups. Digestive symptoms werethe most common drug-related adverse events in both treatmentgroups. Moxifloxacin was statistically atleast as effective as high-dose amoxicillin for treatment ofmild-to-moderate, suspected pneumococcal CAP. Moxifloxacin may be analternative for empiric CAP treatment, especially in areas wheremultidrug resistance in S pneumoniae is sufficientlyprevalent to preclude routine penicillin. Keywords: amoxicillin; community-acquired pneumonia; moxifloxacin; oral therapy; Streptococcus pneumoniae