Back to resultsA Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)
Primary Purpose
Complicated Intra-abdominal Infection
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0826; ertapenem sodium
Comparator: ceftriaxone + metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Intra-abdominal Infection
Eligibility Criteria
Inclusion Criteria: Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
Sites / Locations
Outcomes
Primary Outcome Measures
Favorable clinical response at 7-14 days after treatment
Secondary Outcome Measures
Favorable microbiologic response at 7-14 days after treatment
Full Information
NCT ID
NCT00157898
First Posted
September 7, 2005
Last Updated
February 17, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00157898
Brief Title
A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)
Official Title
A Prospective, Multicenter, Open, Randomized, Comparative Study to Evaluate the Safety and Efficacy of Ertapenem Versus it's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Intra-abdominal Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0826; ertapenem sodium
Intervention Type
Drug
Intervention Name(s)
Comparator: ceftriaxone + metronidazole
Primary Outcome Measure Information:
Title
Favorable clinical response at 7-14 days after treatment
Secondary Outcome Measure Information:
Title
Favorable microbiologic response at 7-14 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)
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