Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT03074760
Status:
UNKNOWN
Last Update Posted:
2017-03-31
First Post:
2017-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Acequias Contamination & Association of Infectious Diseases in Peru
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069578', 'term': 'Waterborne Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2017-03-04', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contamination of acequias', 'timeFrame': 'March 20th - April 1st', 'description': 'Presence of Fecal Coliforms in the acequias'}], 'secondaryOutcomes': [{'measure': 'Proportion of population with infections', 'timeFrame': 'March 20th - May 1st', 'description': 'Proportion of populations with adenovirus, rotavirus and H. pylori infections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Water-Related Diseases']}, 'descriptionModule': {'briefSummary': 'A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation canals that are utilized by the agriculture industry for the cultivation of consumables. Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses. Contamination studies on the acequias in the Lambayeque region have not been performed to date. The purpose of this study is to test contamination of acequias in 9 districts in Lambayeque and determine if a difference in infection rates exists in districts with contaminated acequias vs. districts without contaminated acequias for the following diseases: H. pylori, Adenovirus, Rotavirus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'There is no study population in phase I as it is focused on the districts and their corresponding acequias. Phase II of this study will include participants 18 years of age or older who consent to participate and are from the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently reside in one of the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana\n* 18 years of age or older\n* Consent to participate\n\nExclusion Criteria:\n\n* Currently taking antiviral or antimicrobial medication'}, 'identificationModule': {'nctId': 'NCT03074760', 'briefTitle': 'A Study of Acequias Contamination & Association of Infectious Diseases in Peru', 'organization': {'class': 'OTHER', 'fullName': 'BioRed LLC'}, 'officialTitle': 'A Study of Acequias Contamination & Association of Infectious Diseases in Peru', 'orgStudyIdInfo': {'id': 'CUIRBRG273'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Contaminated acequias', 'interventionNames': ['Diagnostic Test: Adenovirus', 'Diagnostic Test: Rotavirus', 'Diagnostic Test: H. pylori']}, {'label': 'Non-contaminated acequias', 'interventionNames': ['Diagnostic Test: Adenovirus', 'Diagnostic Test: Rotavirus', 'Diagnostic Test: H. pylori']}], 'interventions': [{'name': 'Adenovirus', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic test for the presence of the adenovirus in the population groups', 'armGroupLabels': ['Contaminated acequias', 'Non-contaminated acequias']}, {'name': 'Rotavirus', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic test for the presence of the Rotavirus in the population groups', 'armGroupLabels': ['Contaminated acequias', 'Non-contaminated acequias']}, {'name': 'H. pylori', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic test for the presence of H. pylori infection in the population groups', 'armGroupLabels': ['Contaminated acequias', 'Non-contaminated acequias']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hacienda Pucala', 'state': 'Lambayeque', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Lozado Dominguez', 'role': 'CONTACT'}], 'facility': 'BioRed', 'geoPoint': {'lat': -6.77919, 'lon': -79.60258}}, {'city': 'Pátapo', 'state': 'Lambayeque', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Lozado Dominguez', 'role': 'CONTACT'}], 'facility': 'BioRed', 'geoPoint': {'lat': -6.73315, 'lon': -79.6359}}, {'city': 'Pimentel', 'state': 'Lambayeque', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Lozado Dominguez', 'role': 'CONTACT'}], 'facility': 'BioRed', 'geoPoint': {'lat': -6.83667, 'lon': -79.93417}}, {'city': 'Pomalca', 'state': 'Lambayeque', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Lozado Dominguez', 'role': 'CONTACT'}], 'facility': 'BioRed', 'geoPoint': {'lat': -6.7675, 'lon': -79.77722}}, {'city': 'Tumán', 'state': 'Lambayeque', 'status': 'RECRUITING', 'country': 'Peru', 'contacts': [{'name': 'Lozado Dominguez', 'role': 'CONTACT'}], 'facility': 'BioRed', 'geoPoint': {'lat': -6.74646, 'lon': -79.701}}], 'centralContacts': [{'name': 'Goode', 'role': 'CONTACT', 'email': 'regoode0630@email.campbell.edu', 'phone': '919-672-2212'}], 'overallOfficials': [{'name': 'Robert E Goode', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campbell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioRed LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}