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Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736567
First Posted: August 18, 2008
Last Update Posted: October 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University Early Recognition Center
Information provided by (Responsible Party):
PATH
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Early Recognition Center
  More Information

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT00736567     History of Changes
Other Study ID Numbers: 07-0008
U01AI061187 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2008
First Posted: August 18, 2008
Last Update Posted: October 28, 2014
Last Verified: September 2009

Keywords provided by PATH:
Diarrhea
Diagnostic
Pediatric

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