Back to resultsA Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Primary Purpose
Intra-abdominal Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks
MK0826, /Duration of Treatment : 8 Weeks
Comparator: metronidazole / Duration of Treatment: 8 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Intra-abdominal Infection
Eligibility Criteria
Inclusion Criteria:
- Male or female patients age 18 or older
- Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain
Exclusion Criteria:
- Patient has another infection, other than abdominal
- Female patient is pregnant or planning to become pregnant
Sites / Locations
Outcomes
Primary Outcome Measures
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Secondary Outcome Measures
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Full Information
NCT ID
NCT00481702
First Posted
June 1, 2007
Last Updated
February 17, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00481702
Brief Title
A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Official Title
A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (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
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-abdominal Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks
Intervention Type
Drug
Intervention Name(s)
MK0826, /Duration of Treatment : 8 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: metronidazole / Duration of Treatment: 8 Weeks
Primary Outcome Measure Information:
Title
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Time Frame
4 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients age 18 or older
Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain
Exclusion Criteria:
Patient has another infection, other than abdominal
Female patient is pregnant or planning to become pregnant
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
Citations:
PubMed Identifier
17462256
Citation
Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.
Results Reference
background
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 the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
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