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A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections

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dc.contributor.author Mandell, Lionel A
dc.contributor.author Turgeon, Pierre L
dc.contributor.author Ronalds, Allan R
dc.contributor.author The Canadian Clinical Trials Group,
dc.date.accessioned 2016-06-09T17:49:49Z
dc.date.available 2016-06-09T17:49:49Z
dc.date.issued 1993-1-1
dc.identifier.citation Lionel A Mandell, Pierre L Turgeon, Allan R Ronalds, and The Canadian Clinical Trials Group, “A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections,” Canadian Journal of Infectious Diseases, vol. 4, no. 5, pp. 279-287, 1993. doi:10.1155/1993/567478
dc.identifier.uri http://dx.doi.org/10.1155/1993/567478
dc.identifier.uri http://hdl.handle.net/1993/31481
dc.description.abstract 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.
dc.title A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections
dc.type Journal Article
dc.language.rfc3066 en
dc.description.version Peer Reviewed
dc.rights.holder Copyright © 1993 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.date.updated 2016-06-07T07:04:42Z


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