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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_538 |
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This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
Original label approved November 2001
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0826, /Duration of Treatment : 8 Weeks | Drug | |||
| Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. | 2-weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment. | 4-6 Weeks post-treatment |
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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 |
|---|---|---|---|
| 17381394 | Background | Namias N, Solomkin JS, Jensen EH, Tomassini JE, Abramson MA. Randomized, multicenter, double-blind study of efficacy, safety, and tolerability of intravenous ertapenem versus piperacillin/tazobactam in treatment of complicated intra-abdominal infections in hospitalized adults. Surg Infect (Larchmt). 2007 Feb;8(1):15-28. doi: 10.1089/sur.2006.030. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| 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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