- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092170
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
February 16, 2017 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The duration of treatment is 18 months.
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection
Exclusion Criteria:
- Immune problems
- Kidney problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
January 1, 2004
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
September 21, 2004
First Submitted That Met QC Criteria
September 23, 2004
First Posted (Estimate)
September 24, 2004
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Adnexal Diseases
- Infections
- Communicable Diseases
- Intraabdominal Infections
- Pelvic Inflammatory Disease
- Pelvic Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Ertapenem
- Clavulanic Acid
- Clavulanic Acids
- Ticarcillin
Other Study ID Numbers
- 0826-038
- 2004_062
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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