[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641330":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":47,"centralContacts":55,"locations":64,"responsibleParty":86,"collaborators":36,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":36,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":120,"whyStopped":36,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Mundo Sano Foundation","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will receive a single dose of a pediatric multivitamin tablet as placebo. Following completion of the study follow-up period (Day 21 ± 7), participants in this arm will receive active treatment with albendazole plus ivermectin.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Albendazole","ACTIVE_COMPARATOR","Participants will receive a single oral dose of albendazole 400 mg, the current standard treatment for soil-transmitted helminth infections.",[19],"Drug: Albendazole 400 mg",{"label":21,"type":16,"description":22,"interventionNames":23},"Albendazole Plus Ivermectin","Participants will receive a single oral dose of albendazole 400 mg co-administered with ivermectin dosed according to body weight, following World Health Organization (WHO) dosing recommendations.",[24],"Drug: Albendazole Plus Ivermectin",{"label":26,"type":27,"description":28,"interventionNames":29},"Fixed-Dose Combination Albendazole\u002FIvermectin (FDC)","EXPERIMENTAL","Participants will receive a single oral dose of a fixed-dose combination (FDC) tablet containing albendazole 400 mg and ivermectin 9 mg.",[30],"Drug: Fixed-Dose Combination Albendazole\u002FIvermectin (FDC)",[32,37,41,44],{"type":33,"name":9,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","A single oral dose of a pediatric multivitamin tablet administered as placebo. The placebo contains no active anthelmintic ingredients and is used as a negative control to assess treatment efficacy and safety.",[9],null,{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Albendazole 400 mg","A single oral dose of albendazole 400 mg. Albendazole is the current standard treatment used in preventive chemotherapy programs for soil-transmitted helminth infections.",[15],{"type":33,"name":21,"description":42,"armGroupLabels":43,"otherNames":36},"A single oral dose of albendazole 400 mg co-administered with ivermectin dosed at 200 μg\u002Fkg according to participant body weight and World Health Organization (WHO) dosing recommendations. This regimen represents the current combination therapy shown to improve efficacy against Trichuris trichiura.",[21],{"type":33,"name":26,"description":45,"armGroupLabels":46,"otherNames":36},"A single oral dose of a fixed-dose combination (FDC) tablet containing albendazole 400 mg and ivermectin 9 mg. The FDC is an investigational formulation designed to simplify administration by providing both drugs in a single tablet without the need for weight-based ivermectin dosing.",[26],[48,52],{"name":49,"affiliation":50,"role":51},"Gabriela Matamoros, PhD, MSc, BSc","National Autonomous University of Honduras (UNAH), Tegucigalpa, Honduras","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":5,"role":54},"Alejandro Javier Krolewiecki, PhD, MD","STUDY_DIRECTOR",[56,60],{"name":53,"role":57,"phone":58,"phoneExt":36,"email":59},"CONTACT","+5491131838673","alekrol@mundosano.org",{"name":61,"role":57,"phone":62,"phoneExt":36,"email":63},"Adriana Echazu, PhD, MD","+5493874020307","adrianaechazu@hotmail.com",[65],{"facility":66,"status":36,"city":67,"state":36,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Instituto de Investigaciones en Microbiología, Facultad De Ciencias, Universidad Nacional Autónoma de Honduras","Tegucigalpa","11101","Honduras","HN",{"type":72,"coordinates":73},"Point",[74,75],-87.20681,14.0818,{"lat":75,"lon":74},[78,81,82,85],{"name":49,"role":57,"phone":79,"phoneExt":36,"email":80},"+50432669055","gabriela.matamoros@unah.edu.hn",{"name":49,"role":51,"phone":36,"phoneExt":36,"email":36},{"name":83,"role":84,"phone":36,"phoneExt":36,"email":36},"Marina Gold, PhD","SUB_INVESTIGATOR",{"name":61,"role":84,"phone":36,"phoneExt":36,"email":36},{"type":87,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","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":100,"type":101},368,"ESTIMATED","INTERVENTIONAL",[104],"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.",[107,108,109,110,111],"Trichuriasis","Strongyloidiasis","Ascariasis","Hookworm Infection","Soil-Transmitted Helminthiasis",[113,114,115,116,117,118,119],"HONDURAS","TRICHURIS TRICHIURA","IVERMECTIN","MOSKITIA","SCHOOL AGE CHILDREN","SOIL TRANSMITTED HELMINTHIASIS","ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION","NOT_YET_RECRUITING","2026-06-18",{"date":123,"type":124},"2026-06-23","ACTUAL",{"date":126,"type":101},"2026-11-01",{"date":128,"type":101},"2027-05-31",{"name":5,"class":6},1]