Clinical Trials Directory

Trials / Completed

CompletedNCT00736567

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

Status
Completed
Phase
Study type
Observational
Enrollment
436 (actual)
Sponsor
PATH · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

Timeline

Start date
2008-05-01
Completion
2009-05-01
First posted
2008-08-18
Last updated
2014-10-28

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00736567. Inclusion in this directory is not an endorsement.