Strongyloides Stercoralis InfectionPhase 3TSSINCT03605758
Treatment of Strongyloides Infection
A Phase 3 study testing Ivermectin in people with Strongyloides Stercoralis Infection and Strongyloidiasis, run by Albert Einstein College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strongyloides Stercoralis Infection, Strongyloidiasis
- What is being tested?
- Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 5 Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Positive for Strongyloides serology infection (as determined by ELISA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Ivermectin
- Keywords
- Ivermectin, S. stercoralis, parasite, helminth, Filariform, larvae, Baermann technique
- Medical subject headings
- Strongyloidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Stromectol
Ivermectin is an anti-parasitic
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin on Days 1 and 2 | Active comparator | Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast. Receives: Drug: Ivermectin |
| Ivermectin on Days 1 and 14 | Active comparator | Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast. Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 9-12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startMay 2012
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
Why it stopped: The original study PI passed away. Primary and Study Completion dates revised to reflect last participant examination date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Strongyloides Stercoralis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M Coyle, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605758
- Sponsor's protocol ID
- 2012-233
- Acronym
- TSSI
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2018
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Two Regimens of Ivermectin for the Treatment of Strongyloides Stercoralis Infection
- ClinicalTrials.gov ID
- NCT03605758
- Acronym / sponsor ID
- TSSI / 2012-233
- Keywords
- Ivermectin, S. stercoralis, parasite, helminth, Filariform, larvae, Baermann technique
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The original study PI passed away. Primary and Study Completion dates revised to reflect last participant examination date.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin on Days 1 and 2 | Active comparator | Drug: IvermectinParticipants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast. |
| Ivermectin on Days 1 and 14 | Active comparator | Drug: IvermectinParticipants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Positive for Strongyloides serology infection (as determined by ELISA)
Key exclusion criteria (7 listed)
- Severe intestinal Strongyloides infection
- Disseminated Strongyloidiasis infection
- Pregnant and breastfeeding women
- HTLV-1 co-infection
- Patients with indeterminate results on Strongyloides serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinAlso: StromectolIvermectin is an anti-parasitic | Drug | Ivermectin on Days 1 and 14, Ivermectin on Days 1 and 2 |
Primary outcome
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).
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Coyle, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin in people with Strongyloides Stercoralis Infection and Strongyloidiasis, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment (time frame: 3-4 months post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.