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Trial record 11 of 103 for:    IVERMECTIN

Treatment of Strongyloides Infection (TSSI)

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ClinicalTrials.gov Identifier: NCT03605758
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Christina Marie Coyle, Albert Einstein College of Medicine

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) 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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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 Name: 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 Name: Stromectol




Primary Outcome Measures :
  1. Level of Strongyloides serology as measured by ELISA at 3-4 months post-treatment [ Time Frame: 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).

  2. Level of Strongyloides serology as measured by ELISA at 6-8 months post-treatment [ Time Frame: 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).

  3. Level of Strongyloides serology as measured by ELISA at 9-12 months post-treatment [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605758


Contacts
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Contact: Christina M Coyle, MD 718-918-4455 christina.coyle@einstein.yu.edu
Contact: Herbert B Tanowitz, MD 718-430-3342 herbert.tanowitz@einstein.yu.edu

Locations
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United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Walter Vazquez, MS    718-918-7070    walter.vazquez@nychhc.org   
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Christina M Coyle, MD Albert Einstein College of Medicine

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Responsible Party: Christina Marie Coyle, Prof. Dept. Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03605758     History of Changes
Other Study ID Numbers: 2012-233
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Christina Marie Coyle, Albert Einstein College of Medicine:
Ivermectin
S. stercoralis
parasite
helminth
Filariform
larvae
Baermann technique
Additional relevant MeSH terms:
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Ivermectin
Infection
Communicable Diseases
Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Antiparasitic Agents
Anti-Infective Agents