[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.