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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:
Merck
ClinicalTrials.gov Identifier:
NCT00481702
First received: June 1, 2007
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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: January 2002
Primary Completion Date: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481702

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00481702     History of Changes
Other Study ID Numbers: 2007_558
Study First Received: June 1, 2007
Last Updated: May 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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 May 23, 2013