Randomized comparative trial of imipenem/cilastatin versus aminoglycoside plus amoxycillin plus clindamycin in the treatment of severe intra- and post-operative infections.

In a prospective, randomized, controlled study, clinical and bacteriological efficacy of imipenem/cilastatin (I/C) was compared with a standard combination of aminoglycoside + amoxycillin + clindamycin (C) in patients (pts) with severe intra- and postoperative infections. A total of 84 pts were randomly separated into two groups of 42 pts. Diagnoses were pneumonia n = 21 (14 in I/C group and 7 in C), peritonitis n = 45 (16 in I/C group and 29 in C), septicaemia n = 12 (9 in I/C group and 3 in C), and 7 other infections (3 in I/C group and 4 in C). Doses used were imipenem/cilastatin 1 g q 8 h and amoxycillin 2 g q 8 h plus clindamycin 0.6 g q 6 h, plus netilmicin according to serum concentrations. Success rates were 85.4% (n = 35: 34 cured and one improved) in the I/C group and 83.3% (n = 35: 30 cured and five improved) in the C group. Six pts in group I/C and 7 in group C failed to respond to treatment. One patient in the I/C group was not assessable. 62% of the bacterial isolates were eradicated in the I/C group and 55% in group C. 7% were suppressed in I/C and 5% in C. It is concluded that imipenem/cilastatin is an effective and well-tolerated alternative to antibiotic combinations in severe intra- and post-operative infections. It offers the advantages of fewer drug doses and less renunciation of serum drug concentration monitoring.

RCT Entities:   Population Interventions Outcomes