Mannheim; 4Universit/~tsklinikum Mainz; 5Klinikum Passau; 6Sta, dt. Krankenhaus Hildesheim In an open randomized multicentre trial the safety and efficacy (clinical and bacteriological) of initial monotherapy Meropenem (MEM; l g every 8h, i.v.) have been compared with the standard therapy Imipenem/Cilastatin (IPM; lg every 8h, i.v.) in patients with severe hospital-acquired infections (such as LRTI, peritonitis and sepsis) in patients treated in ICU. A total of 80 patients (40 Meropenem, 40 Imipenem/Cilastatin) entered the study of whom 73/42 were evaluable for clinical/microbiological response. Both treatment groups were comparable with respect to demographic data; mean age MEM: 63.3 years, IPM: 63.2 years; gender: MEM: m 26, f 8; IPM: m 28, f 1 l; duration of therapy : mean days MEM: 8.2 +_ 2.7; IPM: 9.0 _+ 2.8. Diagnosis of primary infection leading to study entry was: LRTI 78.1%, peritonitis 10.9%, sepsis 8.2%, others 2.8%. Patients were clinically evaluated as cured o1 improved by standard criteria. Clinical response in the MEM group (30/34 pts. = 88.2%) was comparable to the IPM group (33/39 pts. = 84.8%). 17 of the MEM patients and 25 of the IPM group were bacteriologically evaluaNe. The causative organisms were mainly S. auretts, H. mfluenzae and P. aerugmosa. Satisfactory' bacteriological response in the MEM group (16/17 pts. = 94.1%) was higher than in the IPM group (22/25 pts. = 88%). Tolerance was good in both treatment groups. In conclusion: Meropenem is well tolerated and clinically and bacteriologically at least as effective as an equivalent dose of' Imipenem/Cilastatin in patients with severe hospital-acquired infections.S 149
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