[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soil-transmitted-helminthiasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soil-transmitted-helminthiasis":32},{"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":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100641330","phase-3-combination-therapies-for-trichuris-trichiura-infection-in-schoolchildren-in-honduras-100641330",false,"NCT07661316","Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras","Randomized, Open-Label, Assessor-Blinded Clinical Trial of Combination Therapies Versus Standard Treatment for Trichuris Trichiura Infection in Schoolchildren in La Moskitia, Honduras","AIM-T","Inclusion Criteria:\n\n* Trichuris trichiura infection documented by quantitative real-time PCR (qPCR) performed within 30 days prior to randomization.\n* Age 6 to 15 years inclusive.\n* Written informed consent provided by a parent or legal guardian. Assent provided by children aged 9 years or older, according to local ethical requirements.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to albendazole or ivermectin.\n* Receipt of an anthelmintic treatment (albendazole, mebendazole, or ivermectin) within 3 months prior to enrollment.\n* Participation in another clinical trial within 3 months prior to enrollment.\n* Severe comorbidity at the investigator's discretion (e.g., diarrhea, tuberculosis, or malaria).\n* Body weight \\\u003C15 kg.\n* Positive pregnancy test or refusal to undergo pregnancy testing in post-menarcheal girls and female adolescents of childbearing potential.","ALL","6 Years","15 Years",{"count":21,"type":22},368,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections.\n\nThe main questions it aims to answer are:\n\n* Are combination treatments of albendazole and ivermectin more effective than albendazole alone for treating Trichuris trichiura infection?\n* Does a fixed-dose combination (FDC) of albendazole and ivermectin achieve cure rates comparable to co-administration of the two drugs?\n* How effective are the different treatment regimens against other soil-transmitted helminths, including Strongyloides stercoralis?\n* What adverse events occur following treatment with the different regimens?\n* How acceptable are the different treatment regimens to children and their caregivers?\n\nResearchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin.\n\nParticipants will:\n\n* Be randomly assigned to one of the four treatment groups.\n* Receive a single dose of the assigned treatment.\n* Provide stool samples before treatment and approximately 21 days after treatment.\n* Undergo laboratory testing using quantitative real-time PCR (qPCR) to detect and quantify helminth infections.\n* Be monitored for adverse events after treatment.\n* Complete acceptability assessments together with their caregivers.\n\nThe study will provide evidence on the efficacy, safety, and acceptability of a fixed-dose combination of albendazole and ivermectin and its potential use as a simplified treatment strategy for the control of soil-transmitted helminth infections in endemic settings.",[28,29,30,31,32],"Trichuriasis","Strongyloidiasis","Ascariasis","Hookworm Infection","Soil-Transmitted Helminthiasis",[34,35,36,37,38,39,40],"HONDURAS","TRICHURIS TRICHIURA","IVERMECTIN","MOSKITIA","SCHOOL AGE CHILDREN","SOIL TRANSMITTED HELMINTHIASIS","ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION","NOT_YET_RECRUITING","2026-06-18",{"date":44,"type":45},"2026-06-23","ACTUAL",{"date":47,"type":22},"2026-11-01",{"date":49,"type":22},"2027-05-31",{"name":51,"class":52},"Mundo Sano Foundation","OTHER"]