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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT03527732
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent signed by either the participant him/herself (≥21 years of age) or by parents and/or caregivers for children/adolescents; and written assent by child/adolescent (aged 6-20 years).
2. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (approximately 3 weeks, 6 months, and 12 months later).
3. Aged ≥6 to \<= 60 years for parallel group trial and ≥6 to \<=12 years for DF study.
4. At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 100 EPG.
Exclusion Criteria:
1. No written informed consent by individual/parents and/or caregiver.
2. Presence of major systemic illnesses, e.g. severe anemia (below 80 g/l Hb according to WHO \[28\]), clinical malaria as assessed by a medical doctor (positive Plasmodium RDT and ≥38 °C ear temperature), upon initial clinical assessment.
3. History of acute or severe chronic disease (e.g. cancer, diabetes, chronic heart, liver or renal disease).
4. Recent use of anthelmintic drug (within past 4 weeks).
5. Attending other clinical trials during the study.
6. Negative or low egg count (less than 100 EPG or less than 2 out of 4 slides positive) diagnostic result for T. trichiura eggs in the stool.
7. Known allergy to study medications (i.e. albendazole and ivermectin).
8. Pregnancy or lactating in the 1st week after birth (according to WHO guidelines within LF control programs \[29\]).
9. Currently taking medication with known interaction (e.g. for albendazole: cimetidine, praziquantel and dexamethasone; for ivermectin: warfarin).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
60 Years
Study:
NCT03527732
Study Brief:
Protocol Section:
NCT03527732