[A randomized, controlled clinical trial of meropenem and imipenem/cilastatin in the treatment of acute bacterial infections].

OBJECTIVE: Meropenem is a new carbapenem antibiotic developed by Sumitomo Pharmaceuticals and shown to resist degradation by renal dehydropeptidase I (DPH-I), an enzyme which exists chiefly in the kidneys and decomposes carbapenem antibiotics. It has a powerful antibacterial activity with broad antibacterial spectrum. The objective of the study is to evaluate the efficacy and safety of meropenem.

METHODS: A randomized, open-label, controlled study was conducted for treating patients with bacterial infections. A total of 112 hospitalized patients were enrolled in the study. 55 patients received meropenem 500 mg every 12 hours (or 1g every 12 hours if necessary) and 57 patients received imipenem/cilastatin 500 mg/500 mg every 12 hours (or 1g/1g every 12 hours if necessary) intravenously. The duration of treatment was 7-14 days in both groups.

RESULTS: 42 of the 55 cases receiving meropenem and 41 of the 57 cases receiving imipenem/cilastatin were assessable for clinical efficacy. The overall efficacy rate was 88.1%(37/42) for the meropenem group and 85.4%(35/41) for the imipenem/cilastatin group, whereas the bacterial eradication rate was 81.1%(30/37) and 84.2%(32/38), respectively. 47(69.1%) of 68 strains isolated from patients produced beta-lactamase. Adverse drug reaction was evaluated in 44 cases of the meropenem group and 41 cases of the imipenem/cilastatin group. The adverse drug reaction rate was 13.6%(6/44) and 12.2%(5/41), respectively. The results showed that there were no statistical differences between these two groups (P > 0.05).

CONCLUSION: Meropenem and imipenem/cilastatin were effective and safe for the treatment of lower respiratory tract infections and urinary tract infections and other infections caused by beta-lactamase-producing strains.