Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-15
SponsorMundo Sano Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugA 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.
Albendazole 400 mg
DrugA single oral dose of albendazole 400 mg. Albendazole is the current standard treatment used in preventive chemotherapy programs for soil-transmitted helminth infections.
Albendazole Plus Ivermectin
DrugA single oral dose of albendazole 400 mg co-administered with ivermectin dosed at 200 μg/kg 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.
Fixed-Dose Combination Albendazole/Ivermectin (FDC)
DrugA 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.
Treatment groups
368 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: AlbendazoleActive comparator 1 intervention
Group C: Albendazole Plus IvermectinActive comparator 1 intervention
Group D: Fixed-Dose Combination Albendazole/Ivermectin (FDC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Trichuris trichiura Cure Rate
Proportion of participants with qPCR-confirmed Trichuris trichiura infection at baseline who test negative for T. trichiura by quantitative real-time PCR (qPCR) at the post-treatment assessment.
Time frame
Day 21 (± 7 days) after treatmentSecondary outcomes
1
Reduction in Trichuris trichiura Parasite Burden
Change in Trichuris trichiura parasite burden measured by quantitative real-time PCR (qPCR) between baseline and post-treatment assessment. Parasite burden will be estimated using species-specific standard curves.
Time frame
Baseline and Day 21 (± 7 days) after treatment2
Strongyloides stercoralis Cure Rate
Proportion of participants with qPCR-confirmed Strongyloides stercoralis infection at baseline who test negative by qPCR at the post-treatment assessment.
Time frame
Day 21 (± 7 days) after treatment3
Cure Rate of Other Soil-Transmitted Helminths
Proportion of participants with qPCR-confirmed infection by Ancylostoma duodenale, Necator americanus, or Ascaris lumbricoides at baseline who test negative for the respective species by quantitative real-time PCR (qPCR) at the post-treatment assessment.
Time frame
Day 21 (± 7 days) after treatment4
Reduction in Parasite Burden of Other Soil-Transmitted Helminths
Change in parasite burden of Strongyloides stercoralis, Ancylostoma duodenale, Necator americanus, and Ascaris lumbricoides between baseline and post-treatment assessment, measured by quantitative real-time PCR (qPCR). Parasite burden will be estimated using species-specific standard curves.
Time frame
Day 21 (± 7 days) after treatmentSponsors and contacts
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Source ClinicalTrials.gov
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