Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura
Status:
Completed
Trial end date:
2023-11-14
Target enrollment:
Participant gender:
Summary
The goal of this parallel open-label randomized controlled superiority trial is to
demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior
to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura
infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.
The main questions it aims to answer are:
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in
terms of cure rates and egg reduction rates against T. trichiura infections in children
aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in
terms of cure rates and egg reduction rates against co-infecting soil-transmitted
helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12
years in Uganda?
- Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole
monotherapy in children aged 6-12 years in Uganda?
Participants will be asked to provide two stool samples at baseline that will be subjected to
microscopic analysis using the Kato-Katz thick smear technique for detection of
soil-transmitted helminth eggs. T. trichiura-infected participants will be:
- clinically examined for general health, anthropometric parameters including height and
weight as well as temperature
- randomly assigned to either receive one single oral dose of combined ivermectin and
albendazole or albendazole monotherapy
- checked for any potential adverse events and will undergo a brief questionnaire on
specific symptoms 3h after drug administration
- asked to provide another two stool samples to be microscopically examined for helminth
eggs 14-21 days post-treatment Researchers will compare individuals treated with
ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura
egg-negative individuals and/or reduction in egg counts differs between these two groups
14-21 days after treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Jennifer Keiser
Collaborator:
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda