Randomized, Open-Label, Assessor-Blinded Clinical Trial of Combination Therapies Versus Standard Treatment for Trichuris Trichiura Infection in Schoolchildren in La Moskitia, Honduras

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.