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

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: Infections; Pelvic Infections

Intervention: MK0826, ertapenem sodium (Drug); Comparator: Ticarcillin/Clavulanate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy

Detailed description: The duration of treatment is 18 months.


Minimum age: 3 Months. Maximum age: 17 Years. Gender(s): Both.


Inclusion Criteria:

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

infection Exclusion Criteria:

- Immune problems

- Kidney problems

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: March 2002
Last updated: November 12, 2014

Page last updated: August 23, 2015

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