F. Colardyn et Kl. Faulkner, INTRAVENOUS MEROPENEM VERSUS IMIPENEM CILASTATIN IN THE TREATMENT OF SERIOUS BACTERIAL-INFECTIONS IN HOSPITALIZED-PATIENTS/, Journal of antimicrobial chemotherapy, 38(3), 1996, pp. 523-537
Meropenem was compared with imipenem/cilastatin for the treatment of s
erious bacterial infections in a randomized, prospective multicentre s
tudy. Both study drugs were given intravenously 1 g every 8 h and no o
ther antimicrobial agents were permitted concomitantly. Of the 204 pat
ients enrolled, the treatment of 177 was evaluable for clinical effica
cy and 115 for bacteriological efficacy. In the clinically evaluable t
reatment population, 75 (83%) of the 90 patients in the meropenem grou
p and 78 (90%) of the 87 in the imipenem/cilastatin group had a single
site of infection whereas the remainder had two or more sites of infe
ction. Infections of the lower respiratory tract and peritoneal cavity
predominated accounting for 95 and 75 cases respectively. Other infec
tions included skin and soft tissue infections, complicated urinary tr
act infections, bacteraemia and a case of meningitis treated with mero
penem and one of mediastinitis treated with imipenem/cilastatin. One h
undred and nineteen (67%) patients were in an intensive care unit, 105
(59%) were receiving assisted ventilation and 93 (53%) of the patient
s had failed previous antibiotic therapy. One hundred and ten organism
s were identified as pathogens in the meropenem group and 109 in the i
mipenem/cilastatin group. Overall, treatment with meropenem was clinic
ally successful in 68 (76%) of 90 cases and imipenem/cilastatin in 67
(77%) of 87 cases and the corresponding eradication rates of bacteria
were 85 of 110 (77%) and 90 of 109 (83%) respectively. Superinfections
due to resistant bacteria occurred in two patients treated with merop
enem and three cases given imipenem/cilastatin. No statistically signi
ficant differences in the clinical or bacteriological outcome were obs
erved between the treatment groups for any of the infection sites anal
ysed. Both drugs were well tolerated with adverse events considered to
be related to therapy being recorded for 10 (9%) of 106 patients trea
ted with meropenem and 12 (12%) of 98 of those who had been given imip
enem/cilastatin. Empirical monotherapy with meropenem was therefore as
effective and as well tolerated as that with imipenem/cilastatin for
the treatment of serious bacterial infections.