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Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
This study has been completed.
Sponsor:
PATH
Collaborators:
Universidade Federal do Ceara
University of Virginia
Micronics, Inc.
Washington University Early Recognition Center
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT00736567
First received: August 14, 2008
Last updated: October 27, 2014
Last verified: September 2009
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | August 14, 2008 | ||
| Last Updated Date | October 27, 2014 | ||
| Start Date ICMJE | May 2008 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | Complete list of historical versions of study NCT00736567 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Evaluation of a Diagnostic Enteric Card for Management of Diarrhea | ||
| Official Title ICMJE | 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 ICMJE | Observational | ||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Retention: Samples Without DNA Description: Stool samples are retained for future research. |
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| Sampling Method | Non-Probability Sample | ||
| Study Population | Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil. | ||
| Condition ICMJE | Diarrhea | ||
| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 436 | ||
| Completion Date | May 2009 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Brazil | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00736567 | ||
| Other Study ID Numbers ICMJE | 07-0008 U01AI061187 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | PATH | ||
| Study Sponsor ICMJE | PATH | ||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||
| PRS Account | PATH | ||
| Verification Date | September 2009 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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