Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group.

As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Keiser
• Collaborator: Public Health Laboratory Ivo de Carneri
• Treatments: Albendazole; Ivermectin

Criteria

Inclusion Criteria:

• individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document)

• having given written informed consent signed by parents/caregivers

• being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)

• having at least two out of four Kato-Katz slides positive for T. trichiura at baseline

• being able and willing to be examined by a study physician before and after treatment

Exclusion Criteria:

• presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <70 g/l)

• history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)

• use of anthelminthic drugs during study period

• known allergy to study medication (i.e., ivermectin or albendazole)

• being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication

• concurrent participation in other clinical trials