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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00389987
First received: October 18, 2006
Last updated: May 20, 2013
Last verified: May 2013

October 18, 2006
May 20, 2013
January 2002
May 2004   (final data collection date for primary outcome measure)
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 ]
In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
Complete list of historical versions of study NCT00389987 on ClinicalTrials.gov Archive Site
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 ]
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.
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Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)(COMPLETED)
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

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.

Original label approved November 2001

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Complicated Intra-Abdominal Infections
  • Drug: MK0826, /Duration of Treatment : 8 Weeks
  • Drug: Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks
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Namias N, Solomkin JS, Jensen EH, Tomassini JE, Abramson MA. Randomized, multicenter, double-blind study of efficacy, safety, and tolerability of intravenous ertapenem versus piperacillin/tazobactam in treatment of complicated intra-abdominal infections in hospitalized adults. Surg Infect (Larchmt). 2007 Feb;8(1):15-28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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May 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00389987
2006_538
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Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP