Treatment of Strongyloides Infection

Study Overview
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Brief Summary
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The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.

Detailed Description
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Patients will be randomly assigned to receive 2 single doses of ivermectin at 200 µg/kg 2 weeks apart versus ivermectin at 200 µg/kg for 2 consecutive days. Patients will be randomized 50-50 to the study groups using the date of birth and a random number table. All patients will be interviewed to obtain the medical history during the initial evaluation. Patients will be asked about demographic data on a questionnaire written in English and Spanish. Physical exams, baseline blood cell counts, serum chemistries, HTLV-1(human T-cell lymphotrophic virus) serology, an IgE (immunoglobulin E), a stool sample for O &P, and a pregnancy test will be performed as routine care all patients currently receive in our clinic.Procedures: Strongyloides serology will be performed in the parasitology laboratory of Jacobi Hospital with an in-house ELISA that uses a 31-kDA(kilodalton) recombinant protein antigen (termed NIE) derived from L3 stage of S. stercoralis and purified from E. coli BL21 containing pET30b plasmid. Once the in-house serology is performed serum will be banked, so it can be available to run in paired with samples taken during follow up visits. Blood samples will be also collected and sent to the Laboratory of Parasitic Diseases (LPD) at the NIAID- National Institutes of Health (NIH) to perform other serological techniques including the Luciferase Immunoprecipitation Systems Assay (LIPS) based on NIE and the recombinant antigen S. stercoralis immunoreactive antigen (SsIR). In addition, stools will be collected from all patients and will be fixated in SAF(sodium acetate, acetic acid and formalin), to check for Strongyloides stercoralis larvae. If possible, fresh stool will be obtained to check for larvae using the Baermann technique and an aliquot will be frozen and sent to the NIH for DNA extraction and PCR(polymerase chain reaction as).

Official Title
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A Comparative Study of Two Regimens of Ivermectin for the Treatment of Strongyloides Stercoralis Infection

Conditions
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Strongyloides Stercoralis Infection, Strongyloidiasis

Intervention / Treatment
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* Drug: Ivermectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Positive for Strongyloides serology infection (as determined by ELISA) Exclusion Criteria: Severe intestinal Strongyloides infection Disseminated Strongyloidiasis infection Pregnant and breastfeeding women HTLV-1 co-infection Patients with indeterminate results on Strongyloides serology Patients who are immunosuppressed Unable to read and understand consent form

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Ivermectin on Days 1 and 2<br>Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast. | Drug: Ivermectin<br>* Ivermectin is an anti-parasitic<br>* Other names: Stromectol;|
| Active Comparator: Ivermectin on Days 1 and 14<br>Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast. | Drug: Ivermectin<br>* Ivermectin is an anti-parasitic<br>* Other names: Stromectol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment | The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. >0.3 OD (optical density) means positive for infection while <0.29 OD means negative (no infection). | 3-4 months post treatment | 
| Level of Strongyloides Serology as Measured by ELISA at 6-8 Months Post-treatment | The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. >0.3 OD (optical density) means positive for infection while <0.29 OD means negative (no infection). | 6-8 months post treatment | 
| Level of Strongyloides Serology as Measured by ELISA at 9-12 Months Post-treatment | The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. >0.3 OD (optical density) means positive for infection while <0.29 OD means negative (no infection). | 9-12 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S. stercoralis, Ivermectin, parasite, helminth, Filariform, larvae, Baermann technique