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A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

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: Complicated Intra-abdominal Infection

Intervention: MK0826; ertapenem sodium (Drug); Comparator: ceftriaxone + metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Favorable clinical response at 7-14 days after treatment

Secondary outcome: Favorable microbiologic response at 7-14 days after treatment


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Males or females between the ages of 18 and 75 who have complicated intra-abdominal


Locations and Contacts

Additional Information

Starting date: January 2004
Last updated: January 28, 2015

Page last updated: August 23, 2015

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