Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

NCT00736567 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 436

Last updated 2014-10-28

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Universidade Federal do Ceara

    collaborator OTHER
  • University of Virginia

    collaborator OTHER
  • Micronics, Inc.

    collaborator INDUSTRY
  • Washington University Early Recognition Center

    collaborator OTHER
  • PATH

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Completion
2009-05-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736567 on ClinicalTrials.gov