Volume 1 Supplement 1
Meropenem versus imipenem/cilastatin in the treatment of serious bacterial infections in ICU: an open randomised multicentre study
- C Verwaest on behalf of the Belgiun Multicentre study group1
© Current Science Ltd 1997
Published: 1 March 1997
In an open randomised multicentre trial the efficacy (clinical and bacteriological) and safety of empirical monotherapy with meropenem (MEM: 1 g every 8 h, iv) have been compared with imipenem/cilastatin (IMI: 1 g every 8 h, iv) in patients with serious bacterial infections at one or more of the following sites: systemic, intra-abdominal and lower respiratory tract infections.
A total of 212 patients (107 MEM, 105 IMI) entered the study of whom 199 (100 MEM, 99 IMI) were evaluable for clinical response and 180 (92 MEM, 88 IMI) for bacteriological response.
In the clinically evaluable population, 85 (85.0%) of the 100 MEM patients and 84 (84.8%) of the 99 IMI patients had a single site of infection whereas the remainder had two or more sites of infection. Infections of the lower respiratory tract and peritoneal cavity predominated accounting for 133 (62.7%) and 58 (27.4%) cases respectively. sepsis/ bacteraemia/ FUO accounted for 21 (9.9%) cases.
Patients were clinically evaluated as satisfactory (completely cured or improved) or unsatisfactory (unchanged or worse).
In an intention-to-treat analysis overall, satisfactory response rates were 84.0% (84 of 100 patients) in the MEM group and 76.8% (76 of 99 patients) in the IMI group. The difference (MEM-IMI) is 7.23%, the 95% CI is -3.76% to 18.22% and the corresponding P-value is 0.199. The satisfactory bacteriological responses were 72.8% (67 of 92 patients) in the MEM group and 69.3% (61 of 88 patients) in the IM1 group. The difference (MEM-IMI) is 3.51%, the 95% CI is -9.74 to 16.75 and the corresponding P-value is 0.604. The causative organisms were mainly Escherichia coli (n = 45) and Pseudomonas aeruginosa (n = 28). The clinically satisfactory response rates for the specific sites were 79.4% (MEM)and 75.0% (IMI) for the lower respiratory tract infections, 96.0% (MEM) and 83.9% (IMI) for the intra-abdominal infections and 85.7% (MEM) and 66.7% (IMI) for the systemic infections.
Both drugs were well tolerated with adverse events considered to be related to the study drug reported for four (3.7%) of 107 patients in the MEM group and for three (2.9%) of 105 patients in the IMI group. No drug-related nausea and vomiting were reported in either group but one drug-related seizure was reported in the IMI group.
In conclusion MEM is clinically and bacteriologically at least as effective as IMI for the treatment of serious bacterial infections in ICU patients and is well tolerated.