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A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00481702
First received: June 1, 2007
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.


Condition Intervention Phase
Intra-abdominal Infection
Drug: Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks
Drug: MK0826, /Duration of Treatment : 8 Weeks
Drug: Comparator: metronidazole / Duration of Treatment: 8 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection [ Time Frame: 2 weeks after treatment ]

Secondary Outcome Measures:
  • That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection [ Time Frame: 4 weeks after treatment ]

Estimated Enrollment: 300
Study Start Date: December 2001
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients age 18 or older
  • Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion Criteria:

  • Patient has another infection, other than abdominal
  • Female patient is pregnant or planning to become pregnant
  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: NCT00481702

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00481702     History of Changes
Other Study ID Numbers: 0826-802, 2007_558
Study First Received: June 1, 2007
Last Updated: November 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Communicable Diseases
Infection
Intraabdominal Infections
Ceftriaxone
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014