Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura

A Randomised, Single-Blinded Phase II Trial to Assess the Efficacy, Safety and Acceptability of Oxantel Pamoate in Comparison to Mebendazole for Trichuris Trichiura Infections in Children Aged 2-12 Years

This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.

Inclusion Criteria:

• Aged between 2 and 12 years.
• Written informed consent signed by parents/caregivers (signature or thumbprint) and, for children aged 6-12 years, written assent from the child.
• Agree to comply with study procedures, including provision of two stool samples at the baseline and at follow-up assessment 14-21 days after treatment, respectively.
• At least two out of four Kato-Katz thick smears positive for T. trichiura at baseline.
• Willing to be examined by a study physician prior to treatment.

Exclusion Criteria:

• Presence or signs of major systemic illness or abnormal physical findings at screening, e.g. severe anaemia (Hb level <80 g/L according to WHO) upon initial clinical assessment.
• Known allergy to study medication (i.e. oxantel pamoate, mebendazole or any of the excipients).
• Use of anthelminthic drugs within 4 weeks before or during study period.
• Being prescribed or taking concomitantly medication with known contraindication or drug interactions with the study medication.
• Actively participating in other clinical trials during the study.
• Pregnancy (female participants that report to have reached menarche