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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Keiser
• Collaborator: Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
• Treatments: Albendazole; Ivermectin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.

• Recent use of anthelmintic drug (within past 4 weeks).

• Attending other experimental research studies.

• Known allergy to study medications (i.e. benzimidazole or ivermectin).