Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT05980156
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Chemoprevention Drugs for School-based Malaria Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Laboratory technicians processing samples will be blinded to participant's study arm."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 646}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-04', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with P. falciparum infection', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'detected by polymerase chain reaction (PCR, binary)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with anemia', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'World Health Organization age-sex definitions (binary)'}, {'measure': 'Mean hemoglobin concentration', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'g/dL (continuous)'}, {'measure': 'Total parasite density', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'log transformed (continuous)'}, {'measure': 'Rate of clinical malaria', 'timeFrame': 'through study completions, approximately 6 months', 'description': 'cumulative incidence'}, {'measure': 'P. falciparum prevalence among children less than 5 years old living in households with study participants', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'detected by PCR'}, {'measure': 'sustained attention', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'code transmission test score (continuous)'}, {'measure': 'selective attention', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'selective attention test score (continuous)'}, {'measure': 'Literacy skills', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'onetest reading test score (continuous)'}, {'measure': 'Math skills', 'timeFrame': '6-8 weeks after the last intervention', 'description': 'onetest math score (continuous)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['malaria', 'school', 'chemoprevention', 'preventive treatment', 'education', 'cognitive function', 'adolescent', 'hemoglobin'], 'conditions': ['Malaria,Falciparum', 'Anemia in Children']}, 'referencesModule': {'references': [{'pmid': '33767384', 'type': 'BACKGROUND', 'citation': 'Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.'}, {'pmid': '33222799', 'type': 'BACKGROUND', 'citation': 'Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.'}]}, 'descriptionModule': {'briefSummary': "This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence in young children sleeping student's households to assess the impact on transmission.", 'detailedDescription': 'Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudents (enrolled in the primary intervention)\n\n* Previously enrolled in NCT05244954\n* Currently enrolled in the study school\n* Plan to attend the study school for the remainder of the school year\n* Parent/guardian available to provide written informed consent Younger children in participant households (enrolled in the Household Prevalence survey)\n* Slept in the household for most nights in the last month\n* Age 6-59 months\n* Parent/guardian available to provide written informed consent\n\nExclusion Criteria:\n\nStudents (enrolled in the primary intervention)\n\n* Current evidence of severe malaria or danger signs\n* Known adverse reaction to the study drugs\n* History of cardiac problems or fainting\n* Taking medications known to prolong QT\n* Family history of prolonged QT\n* Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole\n* Epilepsy\n* Psoriasis Household members (enrolled in the Household Prevalence survey)\n* Household with more than one school-age child enrolled in the study\n* Current evidence of severe malaria or danger signs'}, 'identificationModule': {'nctId': 'NCT05980156', 'briefTitle': 'Comparing Chemoprevention Drugs for School-based Malaria Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens', 'orgStudyIdInfo': {'id': 'HP-00098250v3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)', 'description': 'All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).', 'interventionNames': ['Drug: Dihydroartemisinin-Piperaquine', 'Drug: Chloroquine']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)', 'description': 'All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).', 'interventionNames': ['Drug: Chloroquine', 'Drug: Sulfadoxine pyrimethamine']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Students will not receive preventive treatment.'}], 'interventions': [{'name': 'Dihydroartemisinin-Piperaquine', 'type': 'DRUG', 'otherNames': ['DP', 'D-Artepp', 'DuoCotecxin', 'Artekin', 'Eurartesim', 'Ridmal'], 'description': 'Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).', 'armGroupLabels': ['Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)']}, {'name': 'Chloroquine', 'type': 'DRUG', 'otherNames': ['Aralen', 'Hydroxychloroquine', 'Lariago'], 'description': 'Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.', 'armGroupLabels': ['Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)', 'Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)']}, {'name': 'Sulfadoxine pyrimethamine', 'type': 'DRUG', 'otherNames': ['SP'], 'description': 'Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).', 'armGroupLabels': ['Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Kamuzu University of Health Sciences', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Lauren Cohee, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After results publication', 'ipdSharing': 'YES', 'description': 'all individual participant data that underlie results in a publication', 'accessCriteria': 'Public access with registration to allow tracking'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kamuzu University of Health Sciences', 'class': 'OTHER'}, {'name': 'Doris Duke Charitable Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Lauren Cohee', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}