[Meropenem (Merrem) vs imipenem/cilastatin in hospital treatment of intra-abdominal infections. A multicenter study].

OBJECTIVE: To determine clinical and bacteriological efficacy and tolerability of meropenem and imipenem/cilastatin, given intravenously, in the treatment of intra-abdominal infections in hospitalized patients. EXPERIMENTAL DESIGN: Open multicentre, randomized, parallel groups clinical trial, comparing meropenem and imipenem/cilastatin. ENVIRONMENT: Six Italian hospitals. PATIENTS: Eighty-six hospitalized patients, aged 16 or more, with intra-abdominal infections requiring parenteral antibiotic therapy, were randomized to two treatment groups (43 on meropenem, 43 on imipenem/cilastatin). Eighty-four patients completed the study and 2 were excluded from efficacy analysis. TREATMENT: Meropenem and imipenem/cilastatin were administered intravenously at 1 g TID. Dosage was reduced in patients with renal impairment. Mean treatment duration in clinically evaluable patients was 7.0 days in meropenem group and 7.6 days in imipenem/cilastatin group. MEASUREMENTS: Clinical efficacy evaluated at the end of the therapy and 2-4 weeks after. Bacteriological efficacy before, during, and immediately after the end or the modification of the experimental treatment. All adverse events were recorded. RESULTS: 42/43 (98%) patients on meropenem and 39/41 (95%) on imipenem/cilastatin had satisfactory clinical response. In both groups bacteriological response was satisfactory in 26/27 (96%) evaluable patients. No statistically significant differences were found, both for clinical and bacteriological efficacy. Only two adverse reaction to study drug were observed (1 rash per treatment group). CONCLUSIONS: Meropenem, broad spectrum antibiotic with high stability to human renal DHP-1, given alone for the treatment of intra-abdominal infections is as effective and well tolerated as imipenem/cilastatin.