Efficacy of the Combination Ivermectin and Albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura: a Randomized Controlled Trial

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• Written informed consent for participation signed from caregivers; and written assent by participants.

• Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and at follow-up assessment 14-21 days after treatment.

• Willing to be examined by a study nurse/physician prior to treatment.

• At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.

Locations
Other Locations
Uganda
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala
Time Frame
Start Date: 2023-10-09
Completion Date: 2023-11-14
Participants
Target number of participants: 161
Treatments
Experimental: IVM (200 µg/kg) + ALB (400 mg)
A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose.
Active_comparator: ALB (400mg)
A single tablet of albendazole (400mg), provided as single oral dose.
Sponsors
Collaborators: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
Leads: Jennifer Keiser

This content was sourced from clinicaltrials.gov