Trial Outcomes & Findings for Treatment of Strongyloides Infection (NCT NCT03605758)
NCT ID: NCT03605758
Last Updated: 2023-11-30
Results Overview
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).
TERMINATED
PHASE3
51 participants
3-4 months post treatment
2023-11-30
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
26
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
22
|
24
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Illness
|
0
|
1
|
|
Overall Study
Did not complete all 3 scheduled visits
|
20
|
22
|
Baseline Characteristics
Treatment of Strongyloides Infection
Baseline characteristics by cohort
| Measure |
Ivermectin Administered on Two Consecutive Days (Days 1 and 2)
n=22 Participants
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
|
Ivermectin Administered Two Weeks Apart (Days 1 and 14)
n=26 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-4 months post treatmentPopulation: Serology samples at 3-4 months post treatment were not collected/processed and therefore serology data is not available.
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 measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6-8 months post treatmentPopulation: Serology samples at 6-8 months post treatment were not collected/processed and therefore serology data is not available.
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 measures
Outcome data not reported
PRIMARY outcome
Timeframe: 9-12 months post treatmentPopulation: Serology samples at 9-12 months post treatment were not collected/processed and therefore serology data is not available.
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 measures
Outcome data not reported
Adverse Events
Ivermectin Administered on Two Consecutive Days (Days 1 and 2)
Ivermectin Administered Two Weeks Apart (Days 1 and 14)
Participants Assessed for Events Prior to Randomization
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christina Coyle
Albert Einstein College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place