An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)

NCT ID: NCT00092170

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-01-31

Brief Summary

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

Detailed Description

The duration of treatment is 18 months.

Conditions

Infections; Pelvic Infections

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK0826, ertapenem sodium

Intervention Type: DRUG

Comparator: Ticarcillin/Clavulanate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

Exclusion Criteria

• Immune problems
• Kidney problems

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Yellin AE, Johnson J, Higareda I, Congeni BL, Arrieta AC, Fernsler D, West J, Gesser R. Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg. 2007 Sep;194(3):367-74. doi: 10.1016/j.amjsurg.2007.01.023.

Reference Type: BACKGROUND

PMID: 17693284 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2004_062

Identifier Type: -

Identifier Source: secondary_id

0826-038

Identifier Type: -

Identifier Source: org_study_id