CJIDMM Canadian Journal of Infectious Diseases 1180-2332 Pulsus Group Inc 567478 10.1155/1993/567478 Original Article A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections Mandell Lionel A 1 Turgeon Pierre L 1,2 Ronalds Allan R 3 The Canadian Clinical Trials Group 1 Division of Infectious Diseases Department of Medicine Henderson General Hospital and McMaster University Hamilton Ontario Canada mcmaster.ca 2 Service of Microbiology and Infectious Diseases Hôpital Saint-Luc and l’Université de Montréal Montréal Québec Canada umontreal.ca 3 Department of Medicine and Medical Microbiology The University of Manitoba Winnipeg, Manitoba Canada umanitoba.ca 1993 4 5 279 287 24 8 1992 24 12 1992 1993 Copyright © 1993 Hindawi Publishing Corporation. This open-access article is distributed under the terms of the Creative Commons Attribution Non-Commercial License (CC BY-NC) (http://creativecommons.org/licenses/by-nc/4.0/), which permits reuse, distribution and reproduction of the article, provided that the original work is properly cited and the reuse is restricted to noncommercial purposes.

Objective: A Canadian multicentre clinical trial in the treatment of intra-abdominal and pelvic infections to compare the efficacy and safety of monotherapy using imipenem-cilastatin (imipenem) (500 mg intravenously every 6 h) versus combination therapy with clindamycin/tobramycin (clindamycin 600 mg intravenously every 6 h and tobramycin 1.7 mg/kg intravenously every 8 h).

Methods: Two hundred and fifty patients were entered (88 definite and 162 possible infections) and all were evaluable for analysis of adverse events and intention to treat analysis of efficacy. Dichotomous outcomes used were: cured versus noncured (improved, failed, relapsed).

Results: No statistically significant differences were found with the intention to treat analysis (P=0.88) or with definite infections (P=0.81). For overall bacteriological response, no significant differences were noted (P=0.1). Eleven and 15 patients on imipenem and clindamycin/tobramycin, respectively, were colonized with bacteria. Enterococci colonized four of 11 imipenem cases and five of 15 clindamycin/tobramycin cases while fungi colonized six patients on imipenem and four on clindamycin/tobramycin. Five patients on imipenem and seven on clindamycin/tobramycin developed superinfection. In the imipenem group, one case had a bacterial superinfection while four cases were due to Candida albicans. Seven of seven superinfections on clindamycin/tobramycin were bacterial. Three bacteria initially sensitive to the assigned study drug developed resistance. In two patients on imipenem, Enterococcus faecalis and Pseudomonas aeruginosa became resistant after 14 and 10 days of therapy, respectively. On clindamycin/tobramycin, one instance of Bacteroides fragilis resistance after eight days of therapy was seen. Eighty-three adverse events occurred; 47 in the imipenem group and 36 in the clindamycin/tobramycin group. This resulted in discontinuation of antibacterial therapy in 13 patients, seven of whom were on imipenem and six on clindamycin/tobramycin. Comparison of adverse effects showed statistically significant differences for nausea (P=0.02) and hepatotoxicity (P=0.05) occurring with greater frequency in the imipenem and clindamycin/tobramycin groups, respectively.

Conclusions: These data support the conclusion that monotherapy with imipenem (500 mg intravenously every 6 h) is as efficacious as clindamycin/tobramycin for treatment of intra-abdominal and pelvic infections. Both regimens are well tolerated.

 Imipenem-cilastatin Intra-abdominal infections