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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00389987

First received: October 18, 2006

Last updated: October 16, 2015

Last verified: October 2015

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:

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

U.S. FDA Resources

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

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:	September 2001
Study Completion Date:	May 2004
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 (Adult, Senior)
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

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: NCT00389987

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00389987 History of Changes
Other Study ID Numbers:	0826-037 2006_538
Study First Received:	October 18, 2006
Last Updated:	October 16, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Infection Communicable Diseases Intraabdominal Infections Ertapenem Piperacillin, tazobactam drug combination Penicillanic Acid Piperacillin	Tazobactam Anti-Bacterial Agents Anti-Infective Agents Beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016

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