Death to Onchocerciasis and Lymphatic Filariasis: Comparison of Ivermectin alone with Albendazole (ALB) plus Ivermectin (IVM) in their efficacy against Onchocerciasis

Not Applicable

Completed

• Conditions: Onchocerciasis (Onchocerca volvulus); Infections and Infestations; Onchocerciasis

• Registration Number: ISRCTN50035143
• Lead Sponsor: Case Western Reserve University (USA)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/31536624/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-18
• Study Completion: 2016-04-30
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

Current inclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment:
1. Men and women 18-60 years residing in Ashanti and Central Regions of Ghana
2. =1 accessible nodules
3. Any Mf based on skin snips

Previous inclusion criteria:
1. Men and women 18-60 years residing in Central Region of Ghana
2. =1 accessible nodules
3. =5 Mf/mg based on skin snips

Exclusion Criteria

Current exclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment:
1. Last IVM treatment <7 months
2. Pregnant (do pregnancy test) or breastfeeding
3. 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
4. Weight of <40kg suggesting malnourishment
5. AST/ALT, gamma-glutamyltranspeptidase (?-GT) > 1.5 upper limit of normal
6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)

Previous exclusion criteria:
1. Last IVM treatment <1 year
2. Pregnant (do pregnancy test) or breastfeeding
3. 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
4. Weight of <40kg suggesting malnourishment
5. AST/ALT, gamma-glutamyltranspeptidase (?-GT) > 1.5 upper limit of normal
6. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent fertile female adult worms in accessible nodules at 36 months following initiation of therapy

Secondary Outcome Measures

Name	Time	Method
<br> 1. Percent reduction in skin Mf/mg at 0, 6, 18, and 36 months after initiation of therapy.<br> 2. Percent reduction in total number of live versus dead female worms in nodules at 36 months following initiation of therapy.<br> 3. The number of nodules with intact microfilariae (Mf) at 36 months following initiation of therapy.<br> 4. Assessment of the different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.<br>