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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00736567
Enrollment
436
Registered
2008-08-18
Start date
2008-05-31
Completion date
2009-05-31
Last updated
2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

Diarrhea, Diagnostic, Pediatric

Brief 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.

Interventions

None listed

Sponsors

Universidade Federal do Ceara
CollaboratorOTHER
University of Virginia
CollaboratorOTHER
Micronics, Inc.
CollaboratorINDUSTRY
Washington University Early Recognition Center
CollaboratorOTHER
PATH
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026