A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intra-abdominal Infection
Intervention: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks (Drug); MK0826, /Duration of Treatment : 8 Weeks (Drug); Comparator: metronidazole / Duration of Treatment: 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
Secondary outcome: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: December 2001
Last updated: November 17, 2014
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