Efficacy and Safety of Moxidectin-albendazole Combination for Trichuris Trichiura Infections in School-aged Children: a Double-blind Randomised Controlled Superiority Trial

Moxiped_1

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.

2024-05-14

2024-07-01

2024-07-01

Active (not recruiting)

Early phase I

210

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

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2024-06-06