TSSI: Treatment of Strongyloides Infection

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT03605758

Collaborator

(none)

200

Enrollment

Location

Arms

115

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Strongyloides Stercoralis Infection Strongyloidiasis	Drug: Ivermectin	Phase 3

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ivermectin on Days 1 and 2 Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast.	Drug: Ivermectin Ivermectin is an anti-parasitic Other Names: Stromectol
Active Comparator: Ivermectin on Days 1 and 14 Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast.	Drug: Ivermectin Ivermectin is an anti-parasitic Other Names: Stromectol

Arm

Intervention/Treatment

Active Comparator: Ivermectin on Days 1 and 2

Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast.

Drug: Ivermectin

Ivermectin is an anti-parasitic

Other Names:

Stromectol

Active Comparator: Ivermectin on Days 1 and 14

Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast.

Drug: Ivermectin

Ivermectin is an anti-parasitic

Other Names:

Stromectol

Outcome Measures

Primary Outcome Measures

Level of Strongyloides serology as measured by ELISA at 3-4 months post-treatment [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).
Level of Strongyloides serology as measured by ELISA at 6-8 months post-treatment [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).
Level of Strongyloides serology as measured by ELISA at 9-12 months post-treatment [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).