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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT04410406
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Male or female, aged 18-70 years
* In good general health as evidenced by medical history
* Peripheral night blood W. bancrofti Mf levels ≥40 Mf/mL
* No history of taking antifilarial medications in past 12 months
* Resident of the study area with no plans to change residence in the next 36 months
* For women of childbearing potential, willing to use appropriate method of contraception for one month following each treatment
Exclusion Criteria:
* Pregnancy or currently breastfeeding
* Known allergic reactions to any of the study medications
* Evidence of severe or systemic comorbidities (aside from features of filarial disease), as judged by the principal investigator
* Baseline biochemical abnormalities, as indicated by AST, ALT, or creatinine \> 2 times the upper limit of normal
* Evidence of urinary tract infection as indicated by 3+ nitrites on dipstick (individuals with 1+ or 2+ nitrites will not be excluded) or underlying chronic kidney disease as indicated by 3+ protein or 3+ blood on urine dipstick exam
* Hgb \< 7 gm/dL (any such individuals will be referred to the local health center for evaluation and treatment)
* Positive skin snip for onchocerciasis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04410406
Study Brief:
Protocol Section:
NCT04410406