Treatment of Strongyloides Infection
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/1/2018 |
| Start Date: | May 2012 |
| End Date: | December 2021 |
| Contact: | Christina M Coyle, MD |
| Email: | christina.coyle@einstein.yu.edu |
| Phone: | 718-918-4455 |
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.
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.
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) under the supervision of Dr. Thomas Nutman to
perform other serological techniques including the Luciferase Immunoprecipitation Systems
Assay (LIPS) based on NIE and the recombinant antigen S. stercoralis immunoreactive antigen
(SsIR) (Ramanathan, 2008; Krolewiecki, 2010). 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).
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) under the supervision of Dr. Thomas Nutman to
perform other serological techniques including the Luciferase Immunoprecipitation Systems
Assay (LIPS) based on NIE and the recombinant antigen S. stercoralis immunoreactive antigen
(SsIR) (Ramanathan, 2008; Krolewiecki, 2010). 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).
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
We found this trial at
1
site
1400 Pelham Parkway South
Bronx, New York 10461
Bronx, New York 10461
(718) 918-5000
Phone: 718-918-7070
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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