Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Intra-Abdominal Infections
Intervention: MK0826, /Duration of Treatment : 8 Weeks (Drug); Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.
Secondary outcome: 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.
Detailed description:
Original label approved November 2001
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Related 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.
Starting date: September 2001
Last updated: November 12, 2014
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