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NCT00092170 Clinical Trial

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

Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092170
Other study ID # 0826-038
Secondary ID 2004_062
Status Completed
Phase Phase 2
First received September 21, 2004
Last updated February 16, 2017
Start date March 2002
Est. completion date January 2004

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

Clinical Trial 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.

Description:

The duration of treatment is 18 months.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2004
Est. primary completion date January 2004
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Immune problems

- Kidney problems

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0826, ertapenem sodium

• Comparator: Ticarcillin/Clavulanate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
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