Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

Tracking Information
First Submitted Date	August 14, 2008
First Posted Date	August 18, 2008
Last Update Posted Date	October 28, 2014
Study Start Date	May 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00736567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
Official Title	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	Observational
Study Design	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	Diarrhea
Intervention	Not Provided
Study Groups/Cohorts	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	Completed
Actual Enrollment; (submitted: September 9, 2010)	436
Original Estimated Enrollment; (submitted: August 14, 2008)	1166
Actual Study Completion Date	May 2009
Primary Completion Date	Not Provided
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Brazil
Removed Location Countries
Administrative Information
NCT Number	NCT00736567
Other Study ID Numbers	07-0008; U01AI061187 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	PATH
Study Sponsor	PATH
Collaborators	Universidade Federal do Ceara; University of Virginia; Micronics, Inc.; Washington University Early Recognition Center
Investigators	Not Provided
PRS Account	PATH
Verification Date	September 2009