drugset / Trial / NCT00229112
Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.
Timeline
- Start
- 2001-04
- Primary completion
- 2004-04
- Completion
- 2004-04
Publications
- Background Citron DM, Goldstein EJ, Merriam CV, Lipsky BA, Abramson MA. Bacteriology of moderate-to-severe diabetic foot infections and in vitro activity of antimicrobial agents. J Clin Microbiol. 2007 Sep;45(9):2819-28. doi: 10.1128/JCM.00551-07. Epub 2007 Jul 3.
- Background Armstrong DG, Lipsky BA, Polis AB, Abramson MA. Does dermal thermometry predict clinical outcome in diabetic foot infection? Analysis of data from the SIDESTEP* trial. Int Wound J. 2006 Dec;3(4):302-7. doi: 10.1111/j.1742-481X.2006.00269.x.
- Background Lipsky BA, Sheehan P, Armstrong DG, Tice AD, Polis AB, Abramson MA. Clinical predictors of treatment failure for diabetic foot infections: data from a prospective trial. Int Wound J. 2007 Mar;4(1):30-8. doi: 10.1111/j.1742-481X.2006.00274.x.
- Background Lipsky BA, Polis AB, Lantz KC, Norquist JM, Abramson MA. The value of a wound score for diabetic foot infections in predicting treatment outcome: a prospective analysis from the SIDESTEP trial. Wound Repair Regen. 2009 Sep-Oct;17(5):671-7. doi: 10.1111/j.1524-475X.2009.00521.x. Epub 2009 Aug 11.
- Results Lipsky BA, Armstrong DG, Citron DM, Tice AD, Morgenstern DE, Abramson MA. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet. 2005 Nov 12;366(9498):1695-703. doi: 10.1016/S0140-6736(05)67694-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ertapenem | Small molecule | 1 g | Intravenous |
| Subject | Piperacillin | Small molecule | — | — |
| Subject | Tazobactam | Small molecule | — | — |
Indications
No indication recorded.