In a prospective open randomized multicentre trial pefloxacin (400 mg twice daily, orally) or ceftazidime (2 g twice daily iv) were given to 82 and 88 patients, respectively, with serious bronchopulmonary infection, defined as: infection occurring in high risk patients, or infection that had failed to respond to previous antimicrobials, or infection by a multiresistant pathogen. An additional nitroimidazole was allowed if the culture demonstrated the presence of anaerobes considered pathogenic. Efficacy analysis was possible in 139 patients, 70 in the ceftazidime group, 69 in the pefloxacin group. In the efficacy population, 93 bacterial strains were isolated in the pefloxacin group and 89 in the ceftazidime group. There were more Streptococcus spp. in the ceftazidime group (21) than in the pefloxacin group (14) (P = 0.06). A successful clinical response was observed in 45 patients give pefloxacin (65.2%) and 51 patients given ceftazidime (72.9%). The difference was not statistically significant. There were two relapses with pefloxacin and six with ceftazidime. In the pefloxacin group 86 pathogens (91%) and in the ceftazidime group 78 pathogens (88%) were eradicated. There were 18 and 13 adverse reactions with ceftazidime and pefloxacin, respectively. In this study, pefloxacin was as effective and as safe as ceftazidime in the treatment of severe bronchopulmonary infections.
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