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Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736567
First Posted: August 18, 2008
Last Update Posted: October 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University Early Recognition Center
Information provided by (Responsible Party):
PATH
August 14, 2008
August 18, 2008
October 28, 2014
May 2008
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Complete list of historical versions of study NCT00736567 on ClinicalTrials.gov Archive Site
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Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
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.
Not Provided
Observational
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
Description:
Stool samples are retained for future research.
Non-Probability Sample
Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.
Diarrhea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
May 2009
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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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00736567
07-0008
U01AI061187 ( U.S. NIH Grant/Contract )
No
Not Provided
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PATH
PATH
  • Universidade Federal do Ceara
  • University of Virginia
  • Micronics, Inc.
  • Washington University Early Recognition Center
Not Provided
PATH
September 2009