Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT06720259
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT06720259
Study Brief:
Protocol Section:
NCT06720259