Strongyloides Stercoralis Infection, Strongyloidiasis
Conditions
Keywords
Ivermectin, S. stercoralis, parasite, helminth, Filariform, larvae, Baermann technique
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.
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).
Interventions
DRUGIvermectin
Ivermectin is an anti-parasitic
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment | 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 | 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 | 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). |
Countries
United States
Participant flow
Recruitment details
51 participants consented. One participant expired before treatment, one participant was pregnant, and one participant was unable to be accounted for before treatment. As such, 48 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Ivermectin Administered on Two Consecutive Days (Days 1 and 2) Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days | 22 |
| Ivermectin Administered Two Weeks Apart (Days 1 and 14) Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart | 26 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete all 3 scheduled visits | 20 | 22 |
| Overall Study | Illness | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Ivermectin Administered on Two Consecutive Days (Days 1 and 2) | Ivermectin Administered Two Weeks Apart (Days 1 and 14) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 8 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 37 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized Other, not specified | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 22 participants | 26 participants | 48 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 26 | 1 / 51 |
| other Total, other adverse events | 0 / 22 | 0 / 26 | 0 / 0 |
| serious Total, serious adverse events | 0 / 22 | 0 / 26 | 0 / 0 |
Outcome results
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).
Time frame: 3-4 months post treatment
Population: Serology samples at 3-4 months post treatment were not collected/processed and therefore serology data is not available.
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).
Time frame: 6-8 months post treatment
Population: Serology samples at 6-8 months post treatment were not collected/processed and therefore serology data is not available.
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).
Time frame: 9-12 months post treatment
Population: Serology samples at 9-12 months post treatment were not collected/processed and therefore serology data is not available.