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Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00389987
First received: October 18, 2006
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.


Condition Intervention Phase
Complicated Intra-Abdominal Infections
 Drug: MK0826, /Duration of Treatment : 8 Weeks
Drug: Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. [ Time Frame: 2-weeks post-treatment ]

Secondary Outcome Measures:
  • In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment. [ Time Frame: 4-6 Weeks post-treatment ]

Estimated Enrollment: 300
Study Start Date: January 2002
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Original label approved November 2001

  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 (greater or equal to 18 years of age)
  • Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
  • Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria

Exclusion Criteria:

  • Failure to meet all inclusion criteria.
  • Patients who are considered unlikely to survive the 6-8 week study period.
  • Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389987

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

Publications:

ClinicalTrials.gov Identifier: NCT00389987     History of Changes
Other Study ID Numbers: 2006_538
Study First Received: October 18, 2006
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Ertapenem
Tazobactam
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013