LoiasisPhase 4NCT05085665
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
A Phase 4 study testing Ivermectin in people with Loiasis, run by Washington University School of Medicine at 1 site in Cameroon.
Trial summary
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loiasis
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCameroon
- Study dates
- 30 Jul 2021to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Who cannot join
- known allergy to ivermectin; severe comorbidities
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
Yaoundé
About this study
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
Read the 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.
- Conditions
- Loiasis
- Being tested
- Ivermectin
- Medical subject headings
- Loiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
single dose, 150 ug/kg
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start30 Jul 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LoiasisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Filariasis and Other Tropical Diseases, Cameroon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085665
- Sponsor's protocol ID
- 201909003(2)
- Status last verified
- Aug 2022
- First submitted
- 7 Oct 2021
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
- ClinicalTrials.gov ID
- NCT05085665
- Acronym / sponsor ID
- 201909003(2)
- Conditions
- Loiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Center for Research on Filariasis and Other Tropical Diseases, Cameroon
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 29 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinAll eligible participants received a single dose (150 ug/kg) ivermectin by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Key exclusion criteria (1 listed)
- known allergy to ivermectin; severe comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectinsingle dose, 150 ug/kg | Drug | Ivermectin |
Primary outcome
Cross-reactive Antigenemia
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Loiasis
Not yet recruitingPhase 3
21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia
Loiasis With Positive Blood Microfilaremia, Loiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivermectin in people with Loiasis, run by Washington University School of Medicine at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-reactive Antigenemia (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.