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Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00389987
First received: October 18, 2006
Last updated: February 16, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Complicated Intra-Abdominal Infections | Drug: MK0826, /Duration of Treatment : 8 Weeks Drug: Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (masked roles unspecified) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Piperacillin sodium
Piperacillin
Tazobactam
Ertapenem sodium
Ertapenem
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2001 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Original label approved November 2001
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients (greater or equal to 18 years of age)
- Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
- Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria
Exclusion Criteria:
- Failure to meet all inclusion criteria.
- Patients who are considered unlikely to survive the 6-8 week study period.
- Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00389987
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389987
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00389987 History of Changes |
| Other Study ID Numbers: |
0826-037 2006_538 |
| Study First Received: | October 18, 2006 |
| Last Updated: | February 16, 2017 |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Intraabdominal Infections Tazobactam Penicillanic Acid Piperacillin Ertapenem |
Piperacillin, tazobactam drug combination Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 21, 2017