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OpenTrials
Completed

NCT Number: NCT00736567

Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

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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Key information

Conditions

Diarrhea Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

PATH

Other

Collaborators

  • Micronics, Inc.
  • Universidade Federal do Ceara
  • University of Virginia
  • Washington University Early Recognition Center

Registry information

Official study title

Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil

Important dates

Study start
2008
Study completion
2009
First posted
Aug 18, 2008
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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