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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_083 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0826, ertapenem sodium / Duration of Treatment - 24 weeks | Drug | |||
| Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure/Improvement at discontinuation of IV antibiotic therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure: 1. Day 5 of IV antibiotic therapy; 2.10 days after completion of all antibiotic therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17609322 | 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. | |
| 17199766 | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| 17425547 | 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. |
| 19671126 | 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. |
| 16291062 | Result | 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. |
| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| D000081206 | Duration of Therapy |
| D000078142 | Tazobactam |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
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