Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Trichuriasis, Strongyloidiasis, Ascariasis, Hookworm Infection, Soil-Transmitted Helminthiasis
In brief
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. The main questions it aims to answer are: * Are combination treatments of albendazole and ivermectin more effective than albendazole alone for treating Trichuris trichiura infection? * Does a fixed-dose combination (FDC) of albendazole and ivermectin achieve cure rates comparable to co-administration of the two drugs? * How effective are the different treatment regimens against other soil-transmitted helminths, including Strongyloides stercoralis? * What adverse events occur following treatment with the different regimens? * How acceptable are the different treatment regimens to children and their caregivers? Researchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin. Participants will: * Be randomly assigned to one of the four treatment groups. * Receive a single dose of the assigned treatment. * Provide stool samples before treatment and approximately 21 days after treatment. * Undergo laboratory testing using quantitative real-time PCR (qPCR) to detect and quantify helminth infections. * Be monitored for adverse events after treatment. * Complete acceptability assessments together with their caregivers. The 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.
Key facts
- Study ID
- NCT07661316
- Run by
- Mundo Sano Foundation
- People needed
- 368
- Starts
- 2026-11-01
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Trichuris trichiura infection documented by quantitative real-time PCR (qPCR) performed within 30 days prior to randomization.
- Age 6 to 15 years inclusive.
- Written informed consent provided by a parent or legal guardian. Assent provided by children aged 9 years or older, according to local ethical requirements.
You may not qualify if…
- Known allergy or hypersensitivity to albendazole or ivermectin.
- Receipt of an anthelmintic treatment (albendazole, mebendazole, or ivermectin) within 3 months prior to enrollment.
- Participation in another clinical trial within 3 months prior to enrollment.
- Severe comorbidity at the investigator's discretion (e.g., diarrhea, tuberculosis, or malaria).
- Body weight <15 kg.
- Positive pregnancy test or refusal to undergo pregnancy testing in post-menarcheal girls and female adolescents of childbearing potential.
Where it is running
- Instituto de Investigaciones en Microbiología, Facultad De Ciencias, Universidad Nacional Autónoma de Honduras — Tegucigalpa, Honduras
Full record on ClinicalTrials.gov
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