Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

NCT00736567 | Completed

• 2 other identifiers: 07-0008U01AI061187
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

Diarrhea; Diagnostic; Pediatric

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.

You may qualify if:

• 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.

You may not qualify if:

• 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 & Collaborators

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

Study Sites (1)

Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples are retained for future research.

MeSH Terms

Conditions

Diarrhea; Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: October 28, 2014

Record last verified: 2009-09

Locations

BR (1)