Assessing the Safety and Efficacy of a Combination Therapy for STH in PSAC in Bangladesh

Background (brief): 1. Burden: Soil-transmitted helminth (STH) infections are a major public health problem, primarily affecting children. Although STH prevalence has decreased to 14% in Bangladesh, over 47 million preschool- and school-age children still live in high-risk areas. 2. Knowledge gap: Albendazole shows 94-100% efficacy against A. lumbricoides but only 39-60% against T. trichuria. Ivermectin is also effective against hookworm and T. trichuria. Combining ivermectin with albendazole may be more effective than using either drug alone, but this combined therapy for STH has not yet been studied in Bangladesh. 3. Relevance: STHs significantly impact children's nutrition, hindering health, growth, cognition, and learning. The national deworming program achieved 98.3% treatment coverage, but only 76.2% of PSAC were dewormed using self-prescribed medicines. Hypothesis (if any): The combination therapy of Albendazole and Ivermectin is more effective than Albendazole alone for treating soil-transmitted helminths in preschool-age children in Bangladesh Objectives: 1. To compare the safety and efficacy of Albendazole and Ivermectin combination therapy with Albendazole monotherapy in preschool-aged children 2. To evaluate post-treatment egg reduction rates for various helminths at different time points 3. To determine the median time to re-infection following different anti-helminth interventions for various STH Methods: This Phase IIa single-blinded, randomized controlled trial will evaluate the safety and efficacy of ivermectin and albendazole combination therapy versus standard albendazole monotherapy for STH in 2-5 years in rural Belkuchi, Sirajganj. A total of 110 PSAC with confirmed STH will be randomly assigned to two treatment arms. Field activities and laboratory analysis will use the Kato-Katz technique for microscopic examination. Outcome measures/variables: * Evaluate the safety and efficacy of ivermectin and albendazole combination therapy for STH * Evaluate the statistically significant impact on patient clinical outcomes, cure rate, and egg reduction rate * Correlate changes in Cure Rate and Egg Reduction Rate for different STH at various time points

NCT Number	NCT07045493
Lead Sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh Collaborators: Cures Within Reach
Conditions	Soil Transmitted Helminth (STH) Infections
Enrollment	110 participants
Start Date	2025-07-10
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-14