The efficacy and safety of two oral moxifloxacin regimens compared to oralclarithromycin in the treatment of community-acquired pneumonia

An international multi-centre, randomized, prospective, double-blind study compared oral moxifloxacin (200 mg or 400mg once daily for 10 days) with or al clarithromycin (500mg, twice daily for 10 days) in the treatment of comm unity-acquired pneumonia (CAP). The clinical success rate in the evaluable population at the primary effica cy assessment: 3-5 days after the end of study treatment, was 93.9% in pati ents treated with 200 mg moxifloxacin; 94.4%, with 400 mg moxifloxacin; and 94.3%, with clarithromycin. Clinical success rates were maintained at foll ow-up, 21-28 days after the end of treatment: 90.7% (200mg moxifloxacin), 9 2.8% (400mg moxifloxacin) and 92.2% (clarithromycin): The 95% confidence in tervals indicated that all three treatment regimens were equally effective in treating CAP. At followup, the 400 mg moxifloxacin dose had a slightly h igher observed cure rate than the 200 mg moxifloxacin dose,but this was not statistically significant. The most frequently isolated pathogens were Streptococcus pneumoniae (42%), Haemophilus influenzae (19%), Haemophilus parinfluenzae (10%), Moraxella c atarrhalis (6%), Klebsiella pneumoniae (5%) and Staphylococcus aureus (4%). The bacteriological success rate (eradication and presumed eradication) wa s 72.5% (29/40) for 200 mg moxifloxacin, 78.7% (37/47) for 400 mg moxifloxa cin and 70.7% (29/41) for clarithromycin. The adverse event profile was comparable between the three treatment groups . Most adverse events, possibly or probably related to the study drug, were generally mild or moderate in severity and mostly related to the digestive system: diarrhoea, nausea and abdominal pain in 200mg moxifloxacin patient s; diarrhoea, liver function abnormalities and nausea in 400 mg moxifloxaci n patients and liver function abnormalities, diarrhoea, nausea and taste pe rversion in clarithromycin patients. Study drugs were discontinued because of adverse events in 7/229 (3%) patients treated with 200mg moxifloxacin, 1 1/224 (5%) with moxifloxacin 400mg and 11/222 (5%) with clarithromycin. In all assessments, moxifloxacin was at least as effective clinically, and as well tolerated as clarithromycin in the treatment of CAP. Bacteriologica l success rates in moxifloxacin-treated patients were greater than those of clarithromycin. Moxifloxacin, given once daily, is free of many drug-drug interactions and requires no dosage adjustments in most renal/hepatic defic ient patients.