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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Infection
Intraabdominal Infections
Ertapenem
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014