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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.


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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