Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-25 @ 5:42 PM
Study NCT ID:
NCT02700269
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vanderbilt-Zambia Innovations in Global Health Technologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enhancement of malaria RDT to detect low levels of P falciparum parasites', 'timeFrame': '5 years', 'description': 'The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood.'}]}, 'conditionsModule': {'conditions': ['Malaria Diagnosis']}, 'descriptionModule': {'briefSummary': 'Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those seeking care for suspected malaria in Zambia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals giving written informed consent for themselves\n* Children under the age of 18 for whom a parent or guardian can give consent\n* Individuals seeking care or treatment of suspected or possible malaria\n* Individuals being screened as a contact of someone with recent malaria\n* Other individuals willing to have their blood tested for malaria\n\nExclusion Criteria:\n\n* Anyone over 18 unwilling or unable to provide informed consent\n* Anyone under 18 who does not have a parent or guardian to give consent\n* Anyone between the age of 12 and 18 who does not give assent'}, 'identificationModule': {'nctId': 'NCT02700269', 'acronym': 'VZNIGHT', 'briefTitle': 'Vanderbilt-Zambia Innovations in Global Health Technologies', 'nctIdAliases': ['NCT02698774'], 'organization': {'class': 'OTHER', 'fullName': 'Macha Research Trust, Zambia'}, 'officialTitle': 'Vanderbilt-Zambia Innovations in Global Health Technologies', 'orgStudyIdInfo': {'id': 'MRT15003.2'}, 'secondaryIdInfos': [{'id': '5D43TW009348', 'link': 'https://reporter.nih.gov/quickSearch/5D43TW009348', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'mBEADS', 'type': 'OTHER', 'description': 'Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Choma', 'country': 'Zambia', 'facility': 'Macha Research Trust', 'geoPoint': {'lat': -16.80889, 'lon': 26.9875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Macha Research Trust, Zambia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}