Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
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ClinicalTrials.gov Identifier: NCT00389987 |
Recruitment Status :
Completed
First Posted : October 19, 2006
Last Update Posted : February 17, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Tracking Information | ||||
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First Submitted Date ICMJE | October 18, 2006 | |||
First Posted Date ICMJE | October 19, 2006 | |||
Last Update Posted Date | February 17, 2017 | |||
Study Start Date ICMJE | September 2001 | |||
Actual Primary Completion Date | May 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. [ Time Frame: 2-weeks post-treatment ] | |||
Original Primary Outcome Measures ICMJE |
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: 4-6 Weeks post-treatment ] | |||
Original Secondary Outcome Measures ICMJE |
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. | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037) | |||
Official Title ICMJE | A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults | |||
Brief Summary | 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. | |||
Detailed Description | Original label approved November 2001 | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Complicated Intra-Abdominal Infections | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
300 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2004 | |||
Actual Primary Completion Date | May 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00389987 | |||
Other Study ID Numbers ICMJE | 0826-037 2006_538 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Merck Sharp & Dohme Corp. | |||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |