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.

Timeline

Start

2026-11-01

Primary completion

2027-02-28

Completion

2027-05-31

Publications

• Background 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.
• 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.
• 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.
• 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.

Drugs

Indications