Efficacy and Safety of MOX/ALB Co-administration in SAC

• Status: Active, not recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• individuals aged 6-12 years (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 <80 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., moxidectin or albendazole)

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

• pregnancy (female participants aged 10-12 years)

• concurrent participation in other clinical trials