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.
Summary
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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females between the ages of 18 and 75 who have complicated intra-abdominal
infection.
Locations and Contacts
Additional Information
Starting date: January 2004
Last updated: January 28, 2015
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