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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00157898
First received: September 7, 2005
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Complicated Intra-abdominal Infection
Drug: MK0826; ertapenem sodium
Drug: Comparator: ceftriaxone + metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Favorable clinical response at 7-14 days after treatment

Secondary Outcome Measures:
  • Favorable microbiologic response at 7-14 days after treatment

Enrollment: 134
Study Start Date: January 2004
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157898

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00157898     History of Changes
Other Study ID Numbers: 2005_068, MK0826-050
Study First Received: September 7, 2005
Last Updated: November 4, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ceftriaxone
Ertapenem
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 21, 2014