Prospective randomized comparison of pefloxacin and ampicillin plus gentamicin in the treatment of bacteriologically proven biliary tract infections.

One hundred and eighty-nine patients with acute cholecystitis or cholangitis requiring antibacterial therapy and surgery were randomly allocated in a prospective open study to receive either iv or oral pefloxacin (800 mg per day) or a combination of iv or oral ampicillin (4 g per day) and gentamicin (240 mg per day im). Ninety-two patients had to be withdrawn from the efficacy analysis, mainly because of negative baseline culture, but occasionally because of isolation of bacteria resistant to the study drugs. In the 97 evaluable patients (90 with cholecystitis and 7 with cholangitis) the clinical cure rates were excellent and similar for both groups: 49/50 (98%) for pefloxacin and 45/47 (95.7%) for the combination; the respective bacteriological success rates were 100% and 91.5%. Three patients in the pefloxacin group and six patients in the ampicillin-gentamicin group reported mild and transient side effects.