Loiasis
Conditions
Brief summary
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
Detailed description
A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.
Interventions
DRUGIvermectin
single dose, 150 ug/kg
Sponsors
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Exclusion criteria
* known allergy to ivermectin; severe comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-reactive Antigenemia | 7 days | N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment |
Countries
Cameroon
Participant flow
Recruitment details
potential participants were identified via screening for daytime L. loa Mf counts in communities in the Awae Health District
Pre-assignment details
41 participants were enrolled; 2 were excluded at the initial study visit: one for L. loa Mf counts \>20,000 / mL blood and one due to concerns for significant past medical history
Participants by arm
| Arm | Count |
|---|---|
| Ivermectin All eligible participants received a single dose (150 ug/kg) ivermectin by mouth
Ivermectin: single dose, 150 ug/kg | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Ivermectin | — |
|---|---|---|
| Age, Continuous | 50 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Cameroon | 39 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 34 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Cross-reactive Antigenemia
N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ivermectin | Cross-reactive Antigenemia | 12 Participants |