COMBINATION THERAPIES FOR TRICHURIS TRICHIURA INFECTION IN SCHOOLCHILDREN IN HONDURAS (AIM-T)

RANDOMIZED, OPEN-LABEL, ASSESSOR-BLINDED CLINICAL TRIAL OF COMBINATION THERAPIES VERSUS STANDARD TREATMENT FOR TRICHURIS TRICHIURA INFECTION IN SCHOOLCHILDREN IN LA MOSKITIA, HONDURAS.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Strongyloidiasis; Ascariasis; Trichuriasis; Hookworm Infection; Soil-Transmitted Helminthiasis
• Intervention / Treatment: Drug: Placebo; Drug: Albendazole 400 mg; Drug: Albendazole Plus Ivermectin; Drug: Fixed-Dose Combination Albendazole/Ivermectin (FDC)

Detailed Description

Soil-transmitted helminth (STH) infections remain among the most common neglected tropical diseases worldwide, affecting an estimated 1.5 billion people, particularly in tropical and subtropical regions with limited access to sanitation and healthcare. These infections are associated with anemia, malnutrition, impaired physical and cognitive development in children, and adverse pregnancy outcomes. Despite decades of preventive chemotherapy programs, STH infections continue to represent an important public health challenge in many endemic settings.

Current control strategies rely primarily on mass drug administration (MDA) using albendazole or mebendazole. While these medicines are effective against some STH species, their efficacy against Trichuris trichiura is limited, resulting in persistent transmission despite repeated treatment rounds. In addition, these regimens do not provide adequate treatment for Strongyloides stercoralis, a soil-transmitted helminth capable of causing chronic infection and severe complications in immunocompromised individuals.

Recognizing these limitations, the World Health Organization (WHO) Roadmap for Neglected Tropical Diseases 2021-2030 highlights the need for more effective interventions and strategies that can sustain progress toward the elimination of STHs as a public health problem. Combining existing anthelmintic drugs represents a practical and scalable approach to improving treatment efficacy while reducing the risk of emerging drug resistance.

Ivermectin has emerged as a key candidate for inclusion in integrated STH control strategies. The drug has an extensive record of safe use through large-scale public health programs targeting lymphatic filariasis and onchocerciasis and has been included in the WHO Model List of Essential Medicines. Clinical studies have shown that the combination of albendazole and ivermectin achieves substantially higher cure rates for T. trichiura than albendazole alone and also provides activity against S. stercoralis.

However, the operational use of ivermectin in preventive chemotherapy programs is complicated by the need for weight- or height-based dosing. This requirement increases logistical complexity, extends treatment time, and may result in dosing errors or exclusion of eligible individuals. To address these challenges, a fixed-dose combination (FDC) tablet containing albendazole and ivermectin has been developed. The FDC simplifies administration by providing a standardized dose in a single formulation while maintaining pharmacokinetic exposure comparable to co-administered drugs. Previous Phase II and Phase III studies have demonstrated promising efficacy and safety results, and the product has received a positive scientific opinion from the European Medicines Agency (EMA) for the treatment of multiple helminth infections.

Honduras represents an important setting for evaluating innovative treatment strategies against STHs. More than two million school-aged children require preventive chemotherapy, and T. trichiura remains highly prevalent despite repeated albendazole-based deworming campaigns. Previous studies conducted in Honduras have demonstrated improved efficacy of albendazole plus ivermectin compared with albendazole alone, providing a strong scientific foundation for further evaluation of combination regimens in this population.

The AIM-T study is designed to generate evidence on the efficacy, safety, and acceptability of albendazole-ivermectin combination therapies among schoolchildren living in La Moskitia, a highly endemic region in northeastern Honduras. The study will evaluate a novel fixed-dose combination formulation alongside currently available treatment approaches. In addition to measuring treatment outcomes, the study incorporates molecular diagnostics based on quantitative real-time polymerase chain reaction (qPCR), allowing highly sensitive detection of infections and quantitative assessment of parasite burden before and after treatment.

Participants with confirmed T. trichiura infection will receive a single-dose treatment regimen and will be followed for approximately three weeks. Treatment efficacy will be assessed through post-treatment stool examination using qPCR. Safety monitoring will include active, passive, and remote surveillance for adverse events following treatment. The study will also evaluate treatment acceptability among children and caregivers through structured questionnaires, generating evidence on user experience and preferences that may influence future implementation.

By combining efficacy, safety, and acceptability assessments, this study aims to generate evidence relevant to both clinical practice and public health programs. The findings are expected to inform policy decisions regarding the use of fixed-dose albendazole-ivermectin combinations in school-based and community-based deworming programs in Honduras and other STH-endemic settings. As the first evaluation of this fixed-dose combination in schoolchildren in the Americas, the study represents an important step in the pathway from clinical innovation to programmatic implementation. The results are expected to inform future community-based implementation studies and support the adoption of the intervention by national deworming programs in Honduras and, potentially, throughout the region.

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alejandro Javier Krolewiecki, PhD, MD; Phone Number: +5491131838673; Email: alekrol@mundosano.org
• Study Contact Backup: Name: Adriana Echazu, PhD, MD; Phone Number: +5493874020307; Email: adrianaechazu@hotmail.com

Study Locations

• Honduras
  • Tegucigalpa, Honduras, 11101
    • Instituto de Investigaciones en Microbiología, Facultad De Ciencias, Universidad Nacional Autónoma de Honduras
    • Contact: Gabriela Matamoros, PhD, MSc, BSc; Phone Number: +50432669055; Email: gabriela.matamoros@unah.edu.hn
    • Principal Investigator: Gabriela Matamoros, PhD, MSc, BSc
    • Sub-Investigator: Marina Gold, PhD
    • Sub-Investigator: Adriana Echazu, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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.	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.
Active Comparator: Albendazole; Participants will receive a single oral dose of albendazole 400 mg, the current standard treatment for soil-transmitted helminth infections.	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.
Active Comparator: 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.	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.
Experimental: Fixed-Dose Combination Albendazole/Ivermectin (FDC); Participants will receive a single oral dose of a fixed-dose combination (FDC) tablet containing albendazole 400 mg and ivermectin 9 mg.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 21 (± 7 days) after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Day 21 (± 7 days) after treatment
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.	Day 21 (± 7 days) after treatment
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.	Day 21 (± 7 days) after treatment
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.	Day 21 (± 7 days) after treatment
Safety Assessment	Incidence, type, severity, causality, and outcome of adverse events (AEs) and serious adverse events (SAEs) occurring after treatment administration of each treatment regimen.	From treatment administration through Day 7 after treatment.
Treatment Acceptability	Acceptability of each treatment regimen among participants and caregivers, assessed using a structured post-treatment questionnaire evaluating satisfaction, preferences, and perceived ease of administration.	Day 21 (± 7 days) after treatment

Collaborators and Investigators

• Sponsor: Mundo Sano Foundation
• Investigators: Principal Investigator: Gabriela Matamoros, PhD, MSc, BSc, National Autonomous University of Honduras (UNAH), Tegucigalpa, Honduras; Study Director: Alejandro Javier Krolewiecki, PhD, MD, Mundo Sano Foundation

Publications and helpful links

General Publications

• Fleitas PE, Gandasegui J, Gelaye W, Messa A Jr, Kepha S, van Lieshout L, Algorta J, de Jesus A, Novela V, Mandomando I, Mwandawiro C, Enbiale W, Munoz J, Krolewiecki A. Individual-level analysis of the efficacy of albendazole and albendazole-ivermectin fixed-dose coformulation (FDC) against Trichuris trichiura and hookworms. Acta Trop. 2025 Sep;269:107742. doi: 10.1016/j.actatropica.2025.107742. Epub 2025 Jul 14.
• Krolewiecki A, Kepha S, Fleitas PE, van Lieshout L, Gelaye W, Messa A Jr, Gandasegui J, Algorta J, Novela V, de Jesus A, Rono M, Degarege D, Bedane D, Mwahanje J, Mandomando I, Mwandawiro C, Enbiale W, Munoz J; Stopping Transmission of Intestinal Parasites (STOP) consortium. Albendazole-ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial. Lancet Infect Dis. 2025 May;25(5):548-559. doi: 10.1016/S1473-3099(24)00669-8. Epub 2025 Jan 10.
• Matamoros G, Sanchez A, Gabrie JA, Juarez M, Ceballos L, Escalada A, Rodriguez C, Marti-Soler H, Rueda MM, Canales M, Lanusse C, Cajal P, Alvarez L, Cimino RO, Krolewiecki A. Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):1203-1210. doi: 10.1093/cid/ciab365.
• Echazu A, Bonanno D, Fleitas PE, Jacobson J, Matamoros G, Mwandawiro C, Enbiale W, de Jesus A, Brooks A, Krolewiecki AJ. Fixed-dose ivermectin for Mass Drug Administration: Is it time to leave the dose pole behind? Insights from an Individual Participant Data Meta-Analysis. PLoS Negl Trop Dis. 2025 Sep 15;19(9):e0013059. doi: 10.1371/journal.pntd.0013059. eCollection 2025 Sep.

Helpful Links

• European Medicines Agency (EMA). Ivermectin/Albendazole - opinion on medicine for use outside EU

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: IVERMECTIN; SCHOOL AGE CHILDREN; HONDURAS; TRICHURIS TRICHIURA; MOSKITIA; SOIL TRANSMITTED HELMINTHIASIS; ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Rhabditida Infections; Strongylida Infections; Ascaridida Infections; Trichuriasis; Strongyloidiasis; Hookworm Infections; Ascariasis; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acids, Acyclic; Carboxylic Acids; Macrolides; Lactones; Polyketides; Carbamates; Ivermectin; Albendazole
• Other Study ID Numbers: PI-02-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in the primary study publication will be made available. Shared data will include participant-level baseline and follow-up infection status as determined by qPCR, treatment assignment, primary and secondary efficacy outcomes (including cure rates and parasite burden measurements), and safety data related to adverse events. All shared datasets will be fully de-identified to protect participant confidentiality and will be provided as supplementary material associated with the publication of the study results following study completion.
• IPD Sharing Time Frame: Beginning upon publication of the primary study results and remaining available for at least 5 years.
• IPD Sharing Access Criteria: The de-identified individual participant data (IPD) and supporting documentation will be available to anyone interested in accessing the study data, including researchers, healthcare professionals, policy makers, and members of the public. Available materials will include the de-identified participant-level dataset underlying the published results, data dictionaries, and other supporting documentation necessary to interpret the data. Data will be made available through the Figshare repository and may be accessed directly without restriction upon publication of the primary study results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No