Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:13 PM
Study NCT ID:
NCT00736567
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2008-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool samples are retained for future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2008-08-14', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'Diagnostic', 'Pediatric'], 'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have 3 or greater liquid stools in the past 24 hours.\n* Provide written informed consent from at least one parent in the case of children under 18 years of age.\n* Provide written informed consent for those participants above 18 years of age.\n* Provide assent in the case of children 10 years of age or greater.\n\nExclusion Criteria:\n\n* Previously enrolled in the study.\n* Parents are unwilling or unable to provide written informed consent.\n* Report using antibiotics in the last 30 days.\n* Adolescent (\\<18 years old) parent of a child already enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT00736567', 'briefTitle': 'Evaluation of a Diagnostic Enteric Card for Management of Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil', 'orgStudyIdInfo': {'id': '07-0008'}, 'secondaryIdInfos': [{'id': 'U01AI061187', 'link': 'https://reporter.nih.gov/quickSearch/U01AI061187', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Hospital Infantil Albert Sabin', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Federal do Ceara', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Micronics, Inc.', 'class': 'INDUSTRY'}, {'name': 'Washington University Early Recognition Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}