Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-21 @ 9:08 AM
Study NCT ID:
NCT02654912
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2015-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8682}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Malaria seropositivity in children under five', 'timeFrame': '24 months', 'description': 'Malaria seropositivity in children under five after two-year intervention within health center catchment areas'}], 'secondaryOutcomes': [{'measure': 'Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers', 'timeFrame': '24 months', 'description': 'Quality-improved incidence of malaria data confirmed by malaria rapid diagnostic test (RDT) or microscopy as measured through passive case detection at health posts and health centers in the study area.'}, {'measure': 'PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months', 'timeFrame': '24 months', 'description': 'Polymerase Chain Reaction (PCR)-based testing for malaria parasite prevalence of individuals participating in each community at 0, 30 and 90 days following a reactive research response for a period of 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['malaria', 'elimination', 'surveillance and response', 'dihydroartemisinin+piperaquine'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '29096671', 'type': 'BACKGROUND', 'citation': 'Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee R, Silumbe K, Nyangu J, Larsen DA. Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia. Trials. 2017 Nov 2;18(1):511. doi: 10.1186/s13063-017-2249-0.'}, {'pmid': '36962857', 'type': 'DERIVED', 'citation': 'Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee RW, Mambwe B, Mulube C, Wu L, Tetteh KKA, Drakeley C, Chishimba S, Mwenda M, Silumbe K, Larsen DA. Reactive focal drug administration associated with decreased malaria transmission in an elimination setting: Serological evidence from the cluster-randomized CoRE study. PLOS Glob Public Health. 2022 Dec 5;2(12):e0001295. doi: 10.1371/journal.pgph.0001295. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.', 'detailedDescription': 'The study is a cluster randomized controlled trial designed to evaluate the impact of RFDA intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. It will be conducted among a background population of \\~130,000 people in \\~30,000 households in 16 health center catchment areas across several districts in Southern Province. The government of Zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination.\n\nThe secondary objectives of the study include: 1). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities; 2). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community; 4). Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anyone not excluded and consenting\n\nExclusion Criteria:\n\n* contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin\n* anyone seriously ill\n* currently taking antimalarial medicines\n* allergy to artemisinin drugs\n* pregnant women in first trimester\n* children under 3 months of age\n* reported heart condition'}, 'identificationModule': {'nctId': 'NCT02654912', 'acronym': 'CORE Zambia', 'briefTitle': 'Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'Community-led Responses for Elimination (CoRE): A Cluster Randomized Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration in Malaria Elimination Areas in Southern Province Zambia', 'orgStudyIdInfo': {'id': 'PATH-WIRB-1155095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reactive Focal Drug Administration', 'description': 'This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).', 'interventionNames': ['Drug: Reactive Focal Drug Administration']}, {'type': 'NO_INTERVENTION', 'label': 'Reactive Focal Test and Treat', 'description': 'This is the current standard of care in Southern Province and is described by a reactive response to passively detected index case of malaria. The reactive response consists of testing all individuals within a defined radius of each RDT-confirmed incident malaria case with an RDT and treating all positive individuals with artemether-lumefantrine (AL).'}], 'interventions': [{'name': 'Reactive Focal Drug Administration', 'type': 'DRUG', 'description': 'This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).', 'armGroupLabels': ['Reactive Focal Drug Administration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Choma', 'state': 'Southern Province', 'country': 'Zambia', 'facility': 'Southern province medical office', 'geoPoint': {'lat': -16.80889, 'lon': 26.9875}}], 'overallOfficials': [{'name': 'Daniel Bridges, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akros'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Zambia', 'class': 'OTHER_GOV'}, {'name': 'AKROS Global Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}