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 range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura