Treatment of Strongyloides Infection (TSSI)

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

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.

Study Overview

• Status: Terminated
• Conditions: Strongyloidiasis; Strongyloides Stercoralis Infection
• Intervention / Treatment: Drug: Ivermectin

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christina M Coyle, MD; Phone Number: 718-918-4455; Email: christina.coyle@einstein.yu.edu
• Study Contact Backup: Name: Herbert B Tanowitz, MD; Phone Number: 718-430-3342; Email: herbert.tanowitz@einstein.yu.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Christina M Coyle, MD, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): February 5, 2015
• Study Completion (Actual): February 5, 2015

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Ivermectin; parasite; S. stercoralis; helminth; Filariform; larvae; Baermann technique
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Rhabditida Infections; Infections; Communicable Diseases; Strongyloidiasis; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: 2012-233

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes