Treatment of Strongyloides Infection

Strongyloidiasis Clinical Trial

— TSSI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03605758
• Other study ID #: 2012-233
• Status: Terminated
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: February 5, 2015

Study information

• Verified date: November 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: February 5, 2015
• Est. primary completion date: February 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Strongyloides Stercoralis Infection
• Strongyloidiasis

Intervention

Drug:
• Ivermectin
Ivermectin is an anti-parasitic

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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