- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00736567
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
October 27, 2014 updated by: PATH
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil
PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality.
The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7.
This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users.
It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
436
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ceará
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Fortaleza, Ceará, Brazil
- Hospital Infantil Albert Sabin
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.
Description
Inclusion Criteria:
- Have 3 or greater liquid stools in the past 24 hours.
- Provide written informed consent from at least one parent in the case of children under 18 years of age.
- Provide written informed consent for those participants above 18 years of age.
- Provide assent in the case of children 10 years of age or greater.
Exclusion Criteria:
- Previously enrolled in the study.
- Parents are unwilling or unable to provide written informed consent.
- Report using antibiotics in the last 30 days.
- Adolescent (<18 years old) parent of a child already enrolled in the study.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
May 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
August 14, 2008
First Submitted That Met QC Criteria
August 14, 2008
First Posted (Estimate)
August 18, 2008
Study Record Updates
Last Update Posted (Estimate)
October 28, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0008
- U01AI061187 (U.S. NIH Grant/Contract)
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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