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NCT00157898 Clinical Trial

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

Complicated Intra-abdominal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00157898
Other study ID # 0826-050
Secondary ID MK0826-0502005_0
Status Completed
Phase Phase 4
First received September 7, 2005
Last updated February 17, 2017
Start date January 2004
Est. completion date September 2004

Study information
Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date September 2004
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0826; ertapenem sodium

• Comparator: ceftriaxone + metronidazole

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Favorable clinical response at 7-14 days after treatment
Secondary Favorable microbiologic response at 7-14 days after treatment
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