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Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

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.
 
ClinicalTrials.gov Identifier: NCT00736567
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : October 28, 2014
Sponsor:
Collaborators:
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University Early Recognition Center
Information provided by (Responsible Party):
PATH

Tracking Information
First Submitted Date August 14, 2008
First Posted Date August 18, 2008
Last Update Posted Date October 28, 2014
Study Start Date May 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
Official Title Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Stool samples are retained for future research.
Sampling Method Non-Probability Sample
Study Population Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.
Condition Diarrhea
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 9, 2010)
436
Original Estimated Enrollment
 (submitted: August 14, 2008)
1166
Actual Study Completion Date May 2009
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT00736567
Other Study ID Numbers 07-0008
U01AI061187 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PATH
Study Sponsor PATH
Collaborators
  • Universidade Federal do Ceara
  • University of Virginia
  • Micronics, Inc.
  • Washington University Early Recognition Center
Investigators Not Provided
PRS Account PATH
Verification Date September 2009