A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients...
Date First Received: June 1, 2007
Last Updated: October 8, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: January 2002
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
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”
Condition Keyword(s):
A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks
- Drug: MK0826, /Duration of Treatment : 8 Weeks
- Drug: Comparator: metronidazole / Duration of Treatment: 8 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
- Time Frame: 2 weeks after treatment
- Time Frame: 2 weeks after treatment
Secondary Measures
- That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
- Time Frame: 4 weeks after treatment
- Time Frame: 4 weeks after treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00481702
Study ID Number: 2007_558
ClinicalTrials.gov Identifier: NCT00481702
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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