- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00389987
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
February 16, 2017 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Original label approved November 2001
Study Type
Interventional
Enrollment
300
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 2-weeks post-treatment
|
2-weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 4-6 Weeks post-treatment
|
4-6 Weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
May 1, 2004
Study Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
October 18, 2006
First Submitted That Met QC Criteria
October 18, 2006
First Posted (Estimate)
October 19, 2006
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0826-037
- 2006_538
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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