Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras

Soil‐transmitted helminth (STH) infections remain among the most common neglectedtropical diseases worldwide, affecting an estimated 1.5 billion people, particularly intropical and subtropical regions with limited access to sanitation and healthcare. Theseinfections are associated with anemia, malnutrition, impaired physical and cognitivedevelopment in children, and adverse pregnancy outcomes. Despite decades of preventivechemotherapy programs, STH infections continue to represent an important public healthchallenge in many endemic settings.Current control strategies rely primarily on mass drug administration (MDA) usingalbendazole or mebendazole. While these medicines are effective against some STH species,their efficacy against Trichuris trichiura is limited, resulting in persistenttransmission despite repeated treatment rounds. In addition, these regimens do notprovide adequate treatment for Strongyloides stercoralis, a soil‐transmitted helminthcapable of causing chronic infection and severe complications in immunocompromisedindividuals.Recognizing these limitations, the World Health Organization (WHO) Roadmap for NeglectedTropical Diseases 2021‐2030 highlights the need for more effective interventions andstrategies that can sustain progress toward the elimination of STHs as a public healthproblem. Combining existing anthelmintic drugs represents a practical and scalableapproach to improving treatment efficacy while reducing the risk of emerging drugresistance.Ivermectin has emerged as a key candidate for inclusion in integrated STH controlstrategies. The drug has an extensive record of safe use through large‐scale publichealth programs targeting lymphatic filariasis and onchocerciasis and has been includedin the WHO Model List of Essential Medicines. Clinical studies have shown that thecombination 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 iscomplicated by the need for weight‐ or height‐based dosing. This requirement increaseslogistical complexity, extends treatment time, and may result in dosing errors orexclusion of eligible individuals. To address these challenges, a fixed‐dose combination(FDC) tablet containing albendazole and ivermectin has been developed. The FDC simplifiesadministration by providing a standardized dose in a single formulation while maintainingpharmacokinetic exposure comparable to co‐administered drugs. Previous Phase II and PhaseIII studies have demonstrated promising efficacy and safety results, and the product hasreceived a positive scientific opinion from the European Medicines Agency (EMA) for thetreatment of multiple helminth infections.Honduras represents an important setting for evaluating innovative treatment strategiesagainst STHs. More than two million school‐aged children require preventive chemotherapy,and T. trichiura remains highly prevalent despite repeated albendazole‐based dewormingcampaigns. Previous studies conducted in Honduras have demonstrated improved efficacy ofalbendazole plus ivermectin compared with albendazole alone, providing a strongscientific foundation for further evaluation of combination regimens in this population.The AIM‐T study is designed to generate evidence on the efficacy, safety, andacceptability of albendazole‐ivermectin combination therapies among schoolchildren livingin La Moskitia, a highly endemic region in northeastern Honduras. The study will evaluatea novel fixed‐dose combination formulation alongside currently available treatmentapproaches. In addition to measuring treatment outcomes, the study incorporates moleculardiagnostics based on quantitative real‐time polymerase chain reaction (qPCR), allowinghighly sensitive detection of infections and quantitative assessment of parasite burdenbefore and after treatment.Participants with confirmed T. trichiura infection will receive a single‐dose treatmentregimen and will be followed for approximately three weeks. Treatment efficacy will beassessed through post‐treatment stool examination using qPCR. Safety monitoring willinclude active, passive, and remote surveillance for adverse events following treatment.The study will also evaluate treatment acceptability among children and caregiversthrough structured questionnaires, generating evidence on user experience and preferencesthat may influence future implementation.By combining efficacy, safety, and acceptability assessments, this study aims to generateevidence relevant to both clinical practice and public health programs. The findings areexpected to inform policy decisions regarding the use of fixed‐dosealbendazole‐ivermectin combinations in school‐based and community‐based dewormingprograms in Honduras and other STH‐endemic settings. As the first evaluation of thisfixed‐dose combination in schoolchildren in the Americas, the study represents animportant step in the pathway from clinical innovation to programmatic implementation.The results are expected to inform future community‐based implementation studies andsupport the adoption of the intervention by national deworming programs in Honduras and,potentially, throughout the region.