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 School of Medicine
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00736567
First received: August 14, 2008
Last updated: September 9, 2010
Last verified: September 2009

August 14, 2008
September 9, 2010
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.

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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00736567
07-0008, U01 AI061187
No
Bernhard Weigl, Principal Investigator, PATH
PATH
  • Universidade Federal do Ceara
  • University of Virginia
  • Micronics, Inc.
  • Washington University School of Medicine
Not Provided
PATH
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP