[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.


METHODS
Open multicentre, randomized, parallel groups clinical trial, comparing meropenem and imipenem/cilastatin.


METHODS
Six Italian hospitals.


METHODS
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.


METHODS
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.


METHODS
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.
Tonelli
F
F
Dipartimento di Fisiopatologia Clinica, Policlinico Careggi, Firenze.
D000005:Abdomen; D000293:Adolescent; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy*; D015377:Cilastatin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015378:Imipenem / Q000008:administration & dosage / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D008297:Male; D000077731:Meropenem; D008875:Middle Aged; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D013845:Thienamycins / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors
D011480:Protease Inhibitors; D013845:Thienamycins; D015377:Cilastatin; D015378:Imipenem; D000077731:Meropenem
Meropenem (Merrem) vs imipenem/cilastatina nel trattamento ospedaliero delle infezioni intra-addominali. Studio multicentrico.