Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

This study has been completed.
Sponsor:
Collaborators:
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University School of Medicine
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00736567
First received: August 14, 2008
Last updated: September 9, 2010
Last verified: September 2009
  Purpose

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.


Condition
Diarrhea

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil

Resource links provided by NLM:


Further study details as provided by PATH:

Biospecimen Retention:   Samples Without DNA

Stool samples are retained for future research.


Enrollment: 436
Study Start Date: May 2008
Study Completion Date: May 2009
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736567

Locations
Brazil
Hospital Infantil Albert Sabin
Fortaleza, Ceará, Brazil
Sponsors and Collaborators
PATH
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Bernhard Weigl, Principal Investigator, PATH
ClinicalTrials.gov Identifier: NCT00736567     History of Changes
Other Study ID Numbers: 07-0008, U01 AI061187
Study First Received: August 14, 2008
Last Updated: September 9, 2010
Health Authority: United States: Federal Government
Brazil: National Committee of Ethics in Research

Keywords provided by PATH:
Diarrhea
Diagnostic
Pediatric

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014