Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura (NCT06720259) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Oxantel Pamoate in Children Infected With Trichuris Trichiura
Tanzania163 participantsStarted 2025-04-16
Plain-language summary
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.
Who can participate
Age range2 Years – 12 Years
SexALL
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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
What they're measuring
1
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura