Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras

Summary

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.

Conditions

• Trichuriasis
• Strongyloidiasis
• Ascariasis
• Hookworm Infection
• Soil-Transmitted Helminthiasis

Interventions

DRUG

Placebo

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.

DRUG

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.

DRUG

Albendazole Plus Ivermectin

A 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.

DRUG

Fixed-Dose Combination Albendazole/Ivermectin (FDC)

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.

Sponsors & Collaborators

• Mundo Sano Foundation

  lead OTHER

Principal Investigators

• Gabriela Matamoros, PhD, MSc, BSc · National Autonomous University of Honduras (UNAH), Tegucigalpa, Honduras

• Alejandro Javier Krolewiecki, PhD, MD · Mundo Sano Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-01

Primary Completion

2027-02-28

Completion

2027-05-31

Countries

• Honduras

Study Locations