Randomized trial of imipenem/cilastatin versus gentamicin and clindamycin in mixed flora infections.

Results of a randomized trial comparing imipenem/cilastatin versus the combination of gentamicin plus clindamycin for mixed flora surgical sepsis are reported herein. Seventy-four patients were evaluable, 50 of whom had intra-abdominal sepsis. No imipenem-resistant initially infecting isolates were encountered. When outcome was evaluated on the basis of severity scoring (APACHE II), no difference in mortality was noted. However, therapy in two patients with Pseudomonas emerging from a polymicrobial flora failed with gentamicin, whereas no Pseudomonas failures were noted with imipenem/cilastatin. The major difference noted was in toxicity. There was a 20 percent incidence of nephrotoxicity in gentamicin-treated patients despite serum level monitoring and multiple dose adjustments. The degree of efficacy and the relative tolerability of imipenem/cilastatin in seriously ill surgical patients is demonstrated.

RCT Entities:   Population Interventions Outcomes