A comparison of the safety and efficacy of moxifloxacin (BAY 12-8039) and cefuroxime axetil in the treatment of acute bacterial sinusitis in adults

The aim of this multicentre, randomized study was to compare the efficacy a nd safety of moxifloxacin (BAY 12-8039), a new 8-methoxy fluoroquinolone, w ith that of cefuroxime axetil for the treatment of acute bacterial sinusiti s in adults. Diagnosis was made on a range of clinical signs and symptoms c ombined with radiology and microbiology. A 400 mg dose of moxifloxacin was administered once daily for 7 days to 242 patients and 250 mg twice daily of cefuroxime axetil was administered to 2 51 patients for 10 days. The clinical success rate at the end of treatment in the evaluable population was significantly higher (96.7%) in the moxiflo xacin group (204/211) than in the cefuroxime axetil group (204/225, 90.7%; 95% confidence intervals 1.5%; 10.6%). At follow-up the success rate in the moxifloxacin group was 90.7% and that for the cefuroxime axetil group was 89.2% (95% confidence intervals 4.3%; 5.4%). The predominant pathogens isol ated were Streptococcus pneumoniae and Haemophilus influenzae, followed by Moraxella catarrhalis and Staphylococcus aureus. The bacteriological eradic ation rates were higher for moxifloxacin (94.5%, 103/109) than for cefuroxi me axetil(83.5%, 96/115; 95% CI 3.6%; 19.7%). Only one S. pneumoniae infect ion persisted following moxifloxacin therapy in contrast with three in indi viduals on cefuroxime axetil. There were slightly more adverse events in th e moxifloxacin group than in the cefuroxime axetil group, but there were fe wer serious adverse events following moxifloxacin treatment (three vs, eigh t). The drug was discontinued because of adverse events in 14 moxifloxacin patients and in 11 cefuroxime axetil patients. Overall, in all assessments, moxifloxacin was at least as effective clinica lly and bacteriologically, and as well tolerated, as cefuroxime axetil in t he treatment of acute sinusitis.