A randomized multicentre trial of pefloxacin plus metronidazole and gentamicin plus metronidazole in the treatment of severe intra-abdominal infections

Abstract

In order to compare the efficacy and safety of pefloxacin plus metronidazole with those of gentamicin plus metronidazole, 271 patients with severe intraabdominal infection were enrolled in an open, randomized comparative trial. Seventy males and 66 females (mean age 54 years; range 18-90) were enrolled in the pefloxacin/metronidazole group and 74 males and 61 females (mean age 52 years; range 18-90) in the gentamicin/metronidazole group. After verification of the intra-abdominal infection by laparotomy, drainage or puncture and microbiological cultures, patients received iv either pefloxacin 400 mg, bd, after an 800-mg loading dose, or gentamicin 1.4 mg/kg body weight every 8-24 h depending on the renal function. Metronidazole was given to both groups as a 500 mg intravenous infusion tid. Eighty-seven patients were excluded from the efficacy analysis, principally because of unproven infection, previous antimicrobial therapy or treatment duration less than three days. Ninety-four of 104 patients receiving pefloxacin/metronidazole (90.4%) were cured or improved and there were two failures and eight relapses. In the gentamicin/metronidazole group, 64 of 80 patients (80.0%) were cured or improved while there were three failures, nine relapses, and two deaths. The bacteria originally isolated were eradicated in similar proportions of the patients in the two groups. Eleven of 136 patients receiving pefloxacin/metronidazole (8.1%) and seven of 135 patients given gentamicin/metronidazole (5.2%) had adverse reactions. This study shows that pefloxacin can be considered as effective and safe as gentamicin for the treatment of severe intraabdominal infections.