Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00389987

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 III

Drug Information available for: Piperacillin Piperacillin sodium Tazobactam Ertapenem L 749345

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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:

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.

Study ID Numbers:	2006_538
Study First Received:	October 18, 2006
Last Updated:	October 8, 2007
ClinicalTrials.gov Identifier:	NCT00389987
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ertapenem
Tazobactam
Piperacillin
Piperacillin-tazobactam combination product

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009