Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Study Overview
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Brief Summary
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Ivermectin is currently the best drug to cure strongyloidiasis, but the standard single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.

Official Title
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Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Conditions
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Strongyloidiasis

Intervention / Treatment
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* Drug: Ivermectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients older than 5 years and weighting > 15 kg Current residence in non-endemic areas Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at high titer, irrespective of results of direct tests Exclusion Criteria: Pregnant or lactating women Subjects suffering from CNS diseases Disseminated strongyloidiasis Immunocompromised patients. Lack of informed consent Previous treatment with ivermectin (in the last year)

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ivermectin multiple doses<br>A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16 | Drug: Ivermectin<br>* oral formulation<br>* Other names: Stromectol;|
| Active Comparator: 1 dose ivermectin<br>A single 200 mcg/kg dose of ivermectin | Drug: Ivermectin<br>* oral formulation<br>* Other names: Stromectol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of strongyloides infection | Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality during the 12 months of follow-up. |  | 12 months | 
| Patients with partial response to treatment at T 2 |  | 12 months | 
| Patients with adverse reactions | grade 1 to 5 as defined in detailed protocol | From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion) | 
| Patients with increase in blood ALT over cutoff value |  | Day 17 | 
| Patients with decrease in WBC count below cutoff value |  | Day 17 | 
| Average difference in blood ALT and WBC count at day 17, compared with baseline |  | Day 17 | 
| Average difference in blood eosinophil count at T2, compared with baseline |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strongyloidiasis, Strongyloides stercoralis, Ivermectin