Treatment of Strongyloides Infection

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.
Brief Title
Treatment of Strongyloides Infection
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).
Completion Date
Completion Date Type
Actual
Conditions
Strongyloides Stercoralis Infection
Strongyloidiasis
Eligibility Criteria
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
Inclusion Criteria
Inclusion Criteria:

* At least 18 years of age
* Positive for Strongyloides serology infection (as determined by ELISA)

Gender
All
Gender Based
false
Keywords
Ivermectin
S. stercoralis
parasite
helminth
Filariform
larvae
Baermann technique
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03605758
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2012-233
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Comparative Study of Two Regimens of Ivermectin for the Treatment of Strongyloides Stercoralis Infection
Primary Outcomes
Outcome Description
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).
Outcome Measure
Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment
Outcome Time Frame
3-4 months post treatment
Outcome Description
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).
Outcome Measure
Level of Strongyloides Serology as Measured by ELISA at 6-8 Months Post-treatment
Outcome Time Frame
6-8 months post treatment
Outcome Description
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).
Outcome Measure
Level of Strongyloides Serology as Measured by ELISA at 9-12 Months Post-treatment
Outcome Time Frame
9-12 months post treatment
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Christina Coyle
Investigator Email
christina.coyle@einsteinmed.org
Investigator Phone

Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
STRONGYLOIDIASIS
RHABDITIDA INFECTIONS
SECERNENTEA INFECTIONS
NEMATODE INFECTIONS
HELMINTHIASIS
PARASITIC DISEASES
INFECTIONS
IVERMECTIN
MACROLIDES
POLYKETIDES
LACTONES
ORGANIC CHEMICALS