Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736567
• Other study ID #: 07-0008
• Secondary ID: U01AI061187
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: October 27, 2014
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diarrhea

Locations

Country	Name	City	State
Brazil	Hospital Infantil Albert Sabin	Fortaleza	Ceará

Sponsors (5)

Lead Sponsor	Collaborator
PATH	Micronics, Inc., Universidade Federal do Ceara, University of Virginia, Washington University Early Recognition Center

Country where clinical trial is conducted

Brazil,