Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

This study has been completed.

Sponsor:

Collaborators:

Universidade Federal do Ceara

University of Virginia

Micronics, Inc.

Washington University Early Recognition Center

Information provided by (Responsible Party):

PATH

ClinicalTrials.gov Identifier:

NCT00736567

First received: August 14, 2008

Last updated: October 27, 2014

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	August 14, 2008
Last Updated Date	October 27, 2014
Start Date ^ICMJE	May 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00736567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
Official Title ^ICMJE	Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Stool samples are retained for future research.
Sampling Method	Non-Probability Sample
Study Population	Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.
Condition ^ICMJE	Diarrhea
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	436
Completion Date	May 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Brazil
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00736567
Other Study ID Numbers ^ICMJE	07-0008, U01AI061187
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	PATH
Study Sponsor ^ICMJE	PATH
Collaborators ^ICMJE	Universidade Federal do Ceara University of Virginia Micronics, Inc. Washington University Early Recognition Center
Investigators ^ICMJE	Not Provided
Information Provided By	PATH
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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