IDA for Onchocerciasis
- Conditions
- Onchocerciasis
- Registration Number
- PACTR201906665550709
- Lead Sponsor
- Washington University in St. Louis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 300
1.Men and women 16 – 70 years (at the time of enrollment; ±2 years) of age previously enrolled in the Part 1 study and residing in the area of the study.
2.Participants must have at least 1 palpable subcutaneous nodule (onchocercoma).
3.Participants with baseline skin Mf counts = 3Mf/mg at the time of enrollment into the Part 1 study (Part I, see above).
1.Pregnant and breastfeeding mothers within 1 month of giving birth
2.Severe eye disease at baseline including uveitis, severe glaucoma, , severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below Individuals who are excluded with significant ocular disease will be referred to appropriate ophthalmological care in a health facility (the district hospital) or the any other health facility in Ghana, where affected subjects will obtain appropriate care (University hospital or private ophthalmologist). All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.
a.-j. Ocular exclusion criteria listed in full in the protocol (not possible to list here due to word limit).
3.Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant’s ability to go to school or work or perform routine household chores.
4.Prior allergic / hypersensitivity reactions or intolerance to IVM, albendazole, or DEC.
5.Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.
6.>5 motile Mf in the anterior chamber in either eye at the time of enrollment (six months after pre-treatment with IVM).
7.Any Mf identified in the posterior segment of the eye at the time of enrollment (six months after pre-treatment with IVM).
8.Any other condition identified by study clinicians or investigators that may preclude participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: To compare rates and types of severe adverse events (grade 3 or higher) that occur within 7 days following 1 day or 3 days of treatment with triple drug treatment (DEC with ivermectin and albendazole) with the comparator regimen of 1 day of treatment with ivermectin and albendazole in persons with active Onchocerca volvulus infections six months after pretreatment with ivermectin alone. <br>;Efficacy: To compare the effect of three treatment regimens for killing or sterilizing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.
- Secondary Outcome Measures
Name Time Method Efficacy<br>1.To compare the effect of three treatment regimens for killing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive 18 months after treatment. <br>2.To compare the effects of three treatment regimens for complete clearance of microfilariae from skin snips 3, 12 and 18 months after treatment with IDA. <br>3.To compare the effects of three treatment regimens for preventing reappearance of microfilariae in the skin at 12, and 18 months after treatment with IDA. <br>;Safety:<br>1.To compare rates of adverse events grade 3 or higher by treatment group that occur within 7 days of treatment in the subset of participants who have intraocular microfilariae just prior to treatment with IDA. <br>2.To compare rates of ocular adverse events (any grade) by treatment group that occur within 3 months of treatment with IDA <br>