Randomized multicenter clinical trial with imipenem/cilastatin versus cefotaxime/gentamicin in the treatment of patients with non-life-threatening infections. German and Austrian Imipenem/Cilastatin Study Group

Abstract

In an open, controlled, randomized study the safety and efficacy of imipenem/cilastatin was compared with that of the combination cefotaxime/gentamicin (plus metronidazole in patients with suspected anaerobe infection) in the treatment of 337 patients from 12 German and 5 Austrian centers who had non-life-threatening infections. The evaluation was done on an intention-to-treat basis (i.e. all patients including protocol violators) and according to the protocol (144 patients in the imipenem/cilastatin group and 124 in the cefotaxime/gentamicin group). No significant differences were seen between the two treatment groups in terms of the clinical and bacteriological outcome. The frequency of infusion intolerance and thrombophlebitis was low in both groups (< 2%). The overall rate of adverse events was comparable in the two groups, nausea, vomiting and diarrhea being the most frequent events. Nephrotoxicity, indicated by an increase in serum creatinine, was significantly higher in the cefotaxime/gentamicin group. Imipenem/cilastatin was shown to be as effective as cefotaxime/gentamicin (metronidazole) and appears to be well tolerated.