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

Complicated Intra-Abdominal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389987
• Other study ID #: 0826-037
• Secondary ID: 2006_538
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2006
• Last updated: February 16, 2017
• Start date: September 2001
• Est. completion date: May 2004

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Original label approved November 2001

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-Abdominal Infections
• Infection
• Intraabdominal Infections

Intervention

Drug:
• MK0826, /Duration of Treatment : 8 Weeks

• Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.		2-weeks post-treatment
Secondary	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.		4-6 Weeks post-treatment