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| Name | Class |
|---|---|
| Center for Research on Filariasis and Other Tropical Diseases, Cameroon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | single dose, 150 ug/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT) | Yaoundé | Cameroon |
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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
potential participants were identified via screening for daytime L. loa Mf counts in communities in the Awae Health District
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| ID | Title | Description |
|---|---|---|
| FG000 | Ivermectin | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ivermectin | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 7 days |
|
|
Adverse events were assessed on days 1 - 7 post-treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ivermectin | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthenia | General disorders | Systematic Assessment | asthenia (French): weakness / fatigue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Budge | Washington University in St. Louis | 314-747-5532 | pbudge@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 25, 2019 | Aug 29, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008118 | Loiasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 34 |
| 39 |
| fever | General disorders | Systematic Assessment |
|
| itching | Skin and subcutaneous tissue disorders | Systematic Assessment | pruritus, prurit(French) |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| blurry vision | Eye disorders | Systematic Assessment | vision floue (French) |
|
| decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| lightheadedness | General disorders | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| adenopathy | Immune system disorders | Systematic Assessment |
|
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| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |