[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asymptomatic-malaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asymptomatic-malaria":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100654289","phase-3-optimal-leap-optimizing-dihydroartemisinin-piperaquine-iptsc-intervals-to-advance-learning-executive-function-attendance-and-antimalarial-resistance-surveillance-in-kenyan-schoolchildren-100654289",false,"NCT07798583","OPTIMAL LEAP: Optimizing Dihydroartemisinin-Piperaquine IPTsc Intervals to Advance Learning, Executive Function, Attendance, and Antimalarial Resistance Surveillance in Kenyan Schoolchildren","OPTIMAL LEAP: Optimizing Preventive Treatment Intervals for Malaria to Advance Longitudinal Learning, Executive Function, Attendance, and Pathways","Optimal LEAP","Inclusion Criteria:\n\n* Age 6 to 10 years at enrollment\n* Enrollment in a participating primary school in Siaya County, Kenya\n* Residence within the participating school's catchment area with no plans to relocate during the study period\n* Parent or legal guardian able and willing to provide informed consent\n* Child able and willing to provide assent, as applicable according to local regulations and age requirements\n* Willingness to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to dihydroartemisinin-piperaquine (DP)\n* Severe acute illness requiring urgent medical evaluation or hospitalization at enrollment\n* Known cardiac disease or history of conditions associated with increased risk of QT prolongation\n* Severe malnutrition requiring urgent referral or treatment\n* Recent antimalarial treatment within the protocol-defined washout period\n* Severe anemia (hemoglobin \\\u003C7 g\u002FdL) at screening\n* Measured fever (≥38.0°C) or acute febrile illness requiring evaluation at screening\n* Any medical, social, or behavioral condition that, in the opinion of the investigators, would make participation unsafe or interfere with study participation or interpretation of study results",true,"ALL","6 Years","10 Years",{"count":22,"type":23},1500,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","Malaria remains a major cause of illness among school-aged children in sub-Saharan Africa, many of whom carry asymptomatic Plasmodium falciparum infections that may contribute to anemia, inflammation, school absenteeism, and impaired cognitive performance. Intermittent preventive treatment in school-aged children (IPTsc) is recommended by the World Health Organization in settings with moderate-to-high malaria transmission, but the optimal dosing frequency remains uncertain. This cluster-randomized trial will compare monthly versus quarterly administration of dihydroartemisinin-piperaquine (DP) among 1,500 children aged 6-10 years attending six primary schools in Siaya County, Kenya. The primary objective is to determine whether monthly IPTsc results in greater improvements in executive functioning compared with quarterly IPTsc. Secondary objectives include evaluating effects on literacy, numeracy, school attendance, malaria infection, anemia, inflammatory and metabolic biomarkers, and molecular markers of antimalarial resistance.",[29,30,31],"Malaria","Asymptomatic Malaria","Intermittent Preventive Treatment",[29,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Plasmodium falciparum","Asymptomatic","Anemia","Cognition","School-aged Children","Intermittent preventive treatment","IPTsc","Dihydroartemisinin-piperaquine","Executive function","Literacy","Numeracy","School attendance","Antimalarial resistance","Inflammation","Metabolomics","Kenya","NOT_YET_RECRUITING","2026-08-27",{"date":52,"type":53},"2026-09-01","ACTUAL",{"date":55,"type":23},"2028-01-01",{"date":57,"type":23},"2033-01-01",{"name":59,"class":60},"Indiana University","OTHER"]