Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
This study has been completed.
Sponsor:
PATH
ClinicalTrials.gov Identifier:
NCT00736567
First Posted: August 18, 2008
Last Update Posted: October 28, 2014
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 | ||
| Start Date | May 2008 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures | Not Provided | ||
| Original Primary Outcome Measures | Not Provided | ||
| Change History | Complete list of historical versions of study NCT00736567 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Outcome Measures | Not Provided | ||
| Original Other 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. |
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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 | Diarrhea | ||
| Intervention | 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 | Completed | ||
| Enrollment | 436 | ||
| Completion Date | May 2009 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||
| 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 ) |
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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 | PATH | ||
| Collaborators |
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| Investigators | Not Provided | ||
| PRS Account | PATH | ||
| Verification Date | September 2009 | ||