A Phase 4 interventional study of Ivermectin in Loiasis, sponsored by Washington University School of Medicine. Completed at 1 site in Cameroon. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Basic science
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All eligible participants received a single dose (150 ug/kg) ivermectin by mouth
Drug: Ivermectin
single dose, 150 ug/kg
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
potential participants were identified via screening for daytime L. loa Mf counts in communities in the Awae Health District
| Milestone | Ivermectin |
|---|---|
| Started | 41 |
| Completed | 39 |
| Not completed | 2 |
| Withdrew: Physician decision | 2 |
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
| Participants | Ivermectin |
|---|---|
| Cross-reactive Antigenemia | 12 |
Collected over Adverse events were assessed on days 1 - 7 post-treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ivermectin | 0/39 (0%) | 0/39 (0%) | 34/39 (87.2%) |
| Event | Ivermectin |
|---|---|
| astheniaGeneral disorders | 13/39 |
| itchingSkin and subcutaneous tissue disorders | 11/39 |
| headacheGeneral disorders | 11/39 |
| coughRespiratory, thoracic and mediastinal disorders | 10/39 |
| diarrheaGastrointestinal disorders | 8/39 |
| feverGeneral disorders | 7/39 |
| back painMusculoskeletal and connective tissue disorders | 7/39 |
| decreased appetiteGastrointestinal disorders | 5/39 |
| abdominal painGastrointestinal disorders | 5/39 |
| lightheadednessGeneral disorders | 5/39 |
| Age, Continuous(years) | Ivermectin |
|---|---|
| Median | 50 (44 to 63) |
| Sex: Female, Male(Participants) | Ivermectin |
|---|---|
| Female | 13 |
| Male | 26 |
| Race and Ethnicity Not Collected(Participants) | Ivermectin |
|---|
| Region of Enrollment(Participants) | Ivermectin |
|---|---|
| Cameroon | 39 |
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Loiasis
Washington University School of Medicine