Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-04-23 @ 9:40 AM
Study NCT ID:
NCT02895568
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A dried blood spot sample for study analyses will be collected at the time of blood collection for malaria diagnostic testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-09-05', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)', 'timeFrame': '2 years'}, {'measure': 'Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders', 'timeFrame': '2 yeas'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antimalarial drug', 'Resistance', 'Republic of Chard'], 'conditions': ['Plasmodium Falciparum']}, 'referencesModule': {'references': [{'pmid': '35279140', 'type': 'BACKGROUND', 'citation': 'Das S, Kerah-Hinzoumbe C, Kebfene M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guerin PJ, Imwong M, Dhorda M. Molecular surveillance for operationally relevant genetic polymorphisms in Plasmodium falciparum in Southern Chad, 2016-2017. Malar J. 2022 Mar 12;21(1):83. doi: 10.1186/s12936-022-04095-9.'}]}, 'descriptionModule': {'briefSummary': 'This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.', 'detailedDescription': 'This is a cross-sectional, observational study using dried blood samples collected from P. falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT partner drugs. A maximum of 200 participants will be enrolled at each participating site per year. Study duration is 2 years. Therefore total participant is up to 400.\n\nProspective participants will have blood collected for dried blood spot (DBS) study sample after providing informed consent. Individuals with confirmed P. falciparum infection will have DBS samples included for molecular analyses for known and candidate molecular markers of antimalarial drug resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be the patients presenting at study clinics with signs and symptoms of malaria (including but not limited to headache, body aches, fever, chills, and weakness) and confirmed P. falciparum infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must meet all of the inclusion criteria to participate in the study.\n\n* Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.'}, 'identificationModule': {'nctId': 'NCT02895568', 'briefTitle': 'Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Komé, Doba, Republic of Chad', 'orgStudyIdInfo': {'id': 'WWARN1603'}}, 'contactsLocationsModule': {'locations': [{'city': 'Komé', 'state': 'Doba', 'country': 'Chad', 'facility': 'Study clinic', 'geoPoint': {'lat': 8.60448, 'lon': 16.42846}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Worldwide Antimalarial Resistance Network', 'class': 'NETWORK'}, {'name': 'Mahidol University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}