Status:
COMPLETED
IVM Alone vs ALB + IVM Against Onchocerciasis
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Onchocerciasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Onchocerciasis is a vector-borne nematode parasitic disease that causes severe disability. Onchocerciasis affects approximately 33 million people, mostly in 30 countries in sub-Saharan Africa (with sm...
Detailed Description
Onchocerciasis control programs have relied on annual MDA with IVM at a dose of 150-200 µg/kg. This regimen kills skin (and eye) Mf, thereby reducing disease and (in some areas) transmission. However,...
Eligibility Criteria
Inclusion
- Men and women 18-60 years residing in Ashanti and Central Region of Ghana
- ≥1 accessible nodules
- any Mf/mg based on skin snips
- Willingness to give informed consent to participation in the study
Exclusion
- Last IVM treatment \< 7 months
- Pregnant (do pregnancy test) + breastfeeding
- Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc that prevents or impedes study participation and/or comprehension
- Weight of \<40kg suggesting malnourishment
- AST/ALT, γ-GT \> 1.5 upper limit of normal
- Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)
- Any one or more of the previous criteria is sufficient to exclude study participation
- Not willing or able to give informed consent to participate in the study.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT03238131
Start Date
April 1 2012
End Date
October 1 2016
Last Update
August 29 2017
Active Locations (1)
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1
Committee on Human Research Publications and Ethics
Kumasi, Ashanti Region, Ghana