Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras

NCT07661316 | Not Yet Recruiting Phase 3

• 1 other identifier: PI-02-2026
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HONDURAS; TRICHURIS TRICHIURA; IVERMECTIN; MOSKITIA; SCHOOL AGE CHILDREN; SOIL TRANSMITTED HELMINTHIASIS; ALBENDAZOLE AND IVERMECTIN FIXED DOSE COMBINATION

Outcome Measures

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.

  Day 21 (± 7 days) after treatment

Secondary Outcomes (6)

• Reduction in Trichuris trichiura Parasite Burden

  Baseline and Day 21 (± 7 days) after treatment

• Strongyloides stercoralis Cure Rate

  Day 21 (± 7 days) after treatment

• Cure Rate of Other Soil-Transmitted Helminths

  Day 21 (± 7 days) after treatment

• Reduction in Parasite Burden of Other Soil-Transmitted Helminths

  Day 21 (± 7 days) after treatment

• Safety Assessment

  From treatment administration through Day 7 after treatment.

Study Arms (4)

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.

Drug: Placebo

Albendazole

ACTIVE COMPARATOR

Participants will receive a single oral dose of albendazole 400 mg, the current standard treatment for soil-transmitted helminth infections.

Drug: Albendazole 400 mg

Albendazole Plus Ivermectin

ACTIVE COMPARATOR

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

Fixed-Dose Combination Albendazole/Ivermectin (FDC)

EXPERIMENTAL

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)

Interventions

Placebo 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.

Placebo

Albendazole 400 mg DRUG

A single oral dose of albendazole 400 mg. Albendazole is the current standard treatment used in preventive chemotherapy programs for soil-transmitted helminth infections.

Albendazole

Albendazole Plus Ivermectin DRUG

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.

Albendazole Plus Ivermectin

Fixed-Dose Combination Albendazole/Ivermectin (FDC) DRUG

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.

Fixed-Dose Combination Albendazole/Ivermectin (FDC)

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Mundo Sano Foundation: lead

Study Sites (1)

Instituto de Investigaciones en Microbiología, Facultad De Ciencias, Universidad Nacional Autónoma de Honduras

Tegucigalpa, 11101, Honduras

Location

Related Publications (4)

• 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.

  PMID: 40669531 BACKGROUND

• 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.

  PMID: 39805305 BACKGROUND

• 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.

  PMID: 33906234 BACKGROUND

• 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.

  PMID: 40953116 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Trichuriasis; Strongyloidiasis; Ascariasis; Hookworm Infections

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Rhabditida Infections; Secernentea Infections; Ascaridida Infections; Strongylida Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Gabriela Matamoros, PhD, MSc, BSc

  National Autonomous University of Honduras (UNAH), Tegucigalpa, Honduras

  PRINCIPAL INVESTIGATOR

• Alejandro Javier Krolewiecki, PhD, MD

  Mundo Sano Foundation

  STUDY DIRECTOR

Central Study Contacts

Alejandro Javier Krolewiecki, PhD, MD

CONTACT

+5491131838673; alekrol@mundosano.org

Adriana Echazu, PhD, MD

CONTACT

+5493874020307; adrianaechazu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase III, randomized, open-label, parallel-group clinical trial with blinded assessment of the primary endpoint. The study uses a mixed design incorporating both superiority and non-inferiority objectives. Superiority analyses will evaluate whether the combination regimens (albendazole plus ivermectin co-administration and the fixed-dose combination \[FDC\]) are more effective than albendazole alone and placebo for the treatment of Trichuris trichiura infection. The non-inferiority analysis will evaluate whether the FDC is not inferior to co-administered albendazole plus ivermectin. Participants will be randomly assigned to one of four treatment arms: (1) placebo, (2) albendazole single dose, (3) co-administered albendazole plus ivermectin single dose, or (4) a fixed-dose combination (FDC) of albendazole and ivermectin single dose. The study includes a nested acceptability substudy conducted in parallel with the clinical and parasitological assessments.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning upon publication of the primary study results and remaining available for at least 5 years.
• 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.

Locations

HO (1)