MalariaPhase 4IVIMENCT05605925
Ivermectin-artemisinin Combination Therapy for Eradication of Malaria
A Phase 4 study testing Artemether/lumefantrine and Ivermectin in people with Malaria, run by Makerere University at 1 site in Uganda.
Trial summary
Malaria remains a leading cause of morbidity and mortality globally. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether/lumefantrine and Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUganda
- Study dates
- 4 Aug 2022to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a laboratory malaria diagnosis who consent to participate in the study will be included.
- Willingness to comply with all study procedures.
- Adults patients aged 18-65 years.
Who cannot join
- Participants with known hypersensitivity to Ivermectin
- Patients with a history of asthma
- Participants who live in a household of three or fewer people
- Participants who reside more than 30km from the health care facility and have other members with suspected or confirmed malaria disease in their household at the time of enrolment.
- Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affect ivermectin disposition and clinical outcomes.
- Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan in the last 4 years.
- Active participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
ST. Paul's Health Center
Kasese
Peter Muhindo
About this study
Malaria remains a leading cause of morbidity and mortality globally. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Even with the current prevention strategies including use of impregnated mosquito nets, in 2017, malaria still accounted for 27-34 % of outpatient visits, 19-30 % of hospital admissions, up to 20% of all hospital deaths nationally. A significant percentage of deaths occur at home and are not reported by the facility-based Health Management Information System (HMIS). 27.2% of inpatient deaths among children under five years of age are due to malaria. The transmission of Plasmodium from humans to mosquitoes depends on the presence of mature gametocytes transmission stages. The current first-line treatment for uncomplicated falciparum malaria is artemether lumefantrine, an artemisinin combination therapy (ACT) which rapidly clears asexual parasites and developing gametocytes but leaves mature P. falciparum gametocytes largely unaffected, thus a proportion of patients may transmit malaria after successful ACT treatment and there is an urgent need to prevent this malaria transmission.
Read the detailed description
Malaria remains a leading cause of morbidity and mortality globally, responsible for about one million deaths annually. 90% of these deaths occur in Africa, majority (90%) of whom are children under 5 years old, thus the focus of a global eradication campaign announced in 2007. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Even with the current prevention strategies including use of impregnated mosquito nets, in 2017, malaria still accounted for 27-34 % of outpatient visits, 19-30 % of hospital admissions, up to 20% of all hospital deaths nationally. A significant percentage of deaths occur at home and are not reported by the facility-based Health Management Information System (HMIS). 27.2% of inpatient deaths among children under five years of age are due to malaria. Malaria has an indirect impact on the economy and development in general with socio-economic impact like out-of-pocket expenditure for consultation fees, drugs, transport to distant health facilities, such costs estimated to be as high as USD 3.88 per person per month (26 per household) or 3% of their annual income. Household expenditure for malaria treatment is also a high burden to the Ugandan population, consuming a larger proportion of the incomes in the poorest households. Additionally, malaria has a significant negative impact on the economy of Uganda due to loss of workdays because of sickness, decreased productivity, and decreased school attendance. Workers suffering from malaria may not be able to work for an estimated 5-20 days per episode and given that many people are at times infected multiple times a year, this has substantial financial consequences to families. Industries and agriculture also suffer due to loss of person-hours and decreased worker productivity and investors are usually wary of investing in such countries where malaria rates are high, leading to a loss in investment opportunities. Further, severe malaria impairs children's learning and cognitive ability by as much as 60%, consequently affecting the performance of Uganda's education programs. The transmission of Plasmodium from humans to mosquitoes depends on the presence of mature gametocytes transmission stages. The current first-line treatment for uncomplicated falciparum malaria is artemether lumefantrine, an artemisinin combination therapy (ACT) which rapidly clears asexual parasites and developing gametocytes but leaves mature P. falciparum gametocytes largely unaffected, thus a proportion of patients may transmit malaria after successful ACT treatment and there is an urgent need to prevent this malaria transmission. The current malaria prevention strategies in Uganda focus on the "keep healthy by avoiding malaria" phenomenon without the involvement of the host. Although key in malaria prevention, chemotherapeutic malaria preventive strategies are rarely used in Uganda since the currently available malaria prophylactic agents like mefloquine are only recommended for persons with short stay in malaria endemic settings. In short, to date there are limited malaria chemoprophylaxis options for resident Ugandans generally limiting the practice of malaria prevention.
- Conditions
- Malaria
- Being tested
- Artemether/lumefantrine, Ivermectin
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether/lumefantrineDrug
4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days
IvermectinDrug
IVN 600 mcg/kg/day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | 4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days Receives: Drug: Artemether/lumefantrine |
| Intervention arm | Experimental | IVN 600 mcg/kg/day for 3 days + 4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days Receives: Drug: Artemether/lumefantrine; Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria transmission rates in a household
Malaria transmission rates in a household from an index participant. Index participant is participant who is first diagonised with malaria in that household. The transmission will be assessed using nanopore sequencing to assess for similarity between the malaria falciparum agent of the index participant and that of an household member
Measured: Malaria Transmissibility from index participant to other household members within 28 days
Secondary outcomes (1)
Safety of ivermectin-artemether/lumefantrine in malaria infected patients
Safety of the the use of ivermectin-artemether/lumefantrine in malaria infected patients shall be assessed using the adverse events score scale of 1-mild, 2-moderate, 3-severe, 4-life threatening and 5-death
Measured: daily for 30 days while following up participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start4 Aug 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mukonzo Jackson, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605925
- Sponsor's protocol ID
- MAKSHSREC-2021-237
- Acronym
- IVIME
- Status last verified
- Oct 2022
- First submitted
- 17 Feb 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin-artemisinin Combination Therapy for Eradication of Malaria
- ClinicalTrials.gov ID
- NCT05605925
- Acronym / sponsor ID
- IVIME / MAKSHSREC-2021-237
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malaria remains a leading cause of morbidity and mortality globally. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Even with the current prevention strategies including use of impregnated mosquito nets, in 2017, malaria still accounted for 27-34 % of outpatient visits, 19-30 % of hospital admissions, up to 20% of all hospital deaths nationally. A significant percentage of deaths occur at home and are not reported by the facility-based Health Management Information System (HMIS). 27.2% of inpatient deaths among children under five years of age are due to malaria. The transmission of Plasmodium from humans to mosquitoes depends on the presence of mature gametocytes transmission stages. The current first-line treatment for uncomplicated falciparum malaria is artemether lumefantrine, an artemisinin combination therapy (ACT) which rapidly clears asexual parasites and developing gametocytes but leaves mature P. falciparum gametocytes largely unaffected, thus a proportion of patients may transmit malaria after successful ACT treatment and there is an urgent need to prevent this malaria transmission.
Detailed description
Malaria remains a leading cause of morbidity and mortality globally, responsible for about one million deaths annually. 90% of these deaths occur in Africa, majority (90%) of whom are children under 5 years old, thus the focus of a global eradication campaign announced in 2007. Uganda has the 3rd highest global burden of malaria cases (5%) and the 7th highest level of deaths (3%), accounting for over 10,500 deaths annually. Uganda also has the highest proportion of malaria cases in East and Southern Africa (23.7%). Even with the current prevention strategies including use of impregnated mosquito nets, in 2017, malaria still accounted for 27-34 % of outpatient visits, 19-30 % of hospital admissions, up to 20% of all hospital deaths nationally. A significant percentage of deaths occur at home and are not reported by the facility-based Health Management Information System (HMIS). 27.2% of inpatient deaths among children under five years of age are due to malaria. Malaria has an indirect impact on the economy and development in general with socio-economic impact like out-of-pocket expenditure for consultation fees, drugs, transport to distant health facilities, such costs estimated to be as high as USD 3.88 per person per month (26 per household) or 3% of their annual income. Household expenditure for malaria treatment is also a high burden to the Ugandan population, consuming a larger proportion of the incomes in the poorest households. Additionally, malaria has a significant negative impact on the economy of Uganda due to loss of workdays because of sickness, decreased productivity, and decreased school attendance. Workers suffering from malaria may not be able to work for an estimated 5-20 days per episode and given that many people are at times infected multiple times a year, this has substantial financial consequences to families. Industries and agriculture also suffer due to loss of person-hours and decreased worker productivity and investors are usually wary of investing in such countries where malaria rates are high, leading to a loss in investment opportunities. Further, severe malaria impairs children's learning and cognitive ability by as much as 60%, consequently affecting the performance of Uganda's education programs. The transmission of Plasmodium from humans to mosquitoes depends on the presence of mature gametocytes transmission stages. The current first-line treatment for uncomplicated falciparum malaria is artemether lumefantrine, an artemisinin combination therapy (ACT) which rapidly clears asexual parasites and developing gametocytes but leaves mature P. falciparum gametocytes largely unaffected, thus a proportion of patients may transmit malaria after successful ACT treatment and there is an urgent need to prevent this malaria transmission. The current malaria prevention strategies in Uganda focus on the "keep healthy by avoiding malaria" phenomenon without the involvement of the host. Although key in malaria prevention, chemotherapeutic malaria preventive strategies are rarely used in Uganda since the currently available malaria prophylactic agents like mefloquine are only recommended for persons with short stay in malaria endemic settings. In short, to date there are limited malaria chemoprophylaxis options for resident Ugandans generally limiting the practice of malaria prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Artemether/lumefantrine4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days |
| Intervention arm | Experimental | Drug: Artemether/lumefantrine, Drug: IvermectinIVN 600 mcg/kg/day for 3 days + 4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with a laboratory malaria diagnosis who consent to participate in the study will be included.
- Willingness to comply with all study procedures.
- Adults patients aged 18-65 years.
Key exclusion criteria (7 listed)
- Participants with known hypersensitivity to Ivermectin
- Patients with a history of asthma
- Participants who live in a household of three or fewer people
- Participants who reside more than 30km from the health care facility and have other members with suspected or confirmed malaria disease in their household at the time of enrolment.
- Co-treatment with either strong cytochrome p-450 inducers including: rifampicin, carbamazepine and barbiturates or inhibitors: isoniazid, clofazimine that might potentially affect ivermectin disposition and clinical outcomes.
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 |
|---|---|---|
| Artemether/lumefantrine4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days | Drug | Control arm, Intervention arm |
| IvermectinIVN 600 mcg/kg/day for 3 days | Drug | Intervention arm |
Primary outcome
Malaria transmission rates in a household
Time frame: Malaria Transmissibility from index participant to other household members within 28 days
Malaria transmission rates in a household from an index participant. Index participant is participant who is first diagonised with malaria in that household. The transmission will be assessed using nanopore sequencing to assess for similarity between the malaria falciparum agent of the index participant and that of an household member
1 secondary outcome
Safety of ivermectin-artemether/lumefantrine in malaria infected patients
Time frame: daily for 30 days while following up participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
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 Artemether/lumefantrine and Ivermectin in people with Malaria, run by Makerere University at 1 site in Uganda.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Nov 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackson Mukonzo, PhD (+256758113468, mukojack@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria transmission rates in a household (time frame: Malaria Transmissibility from index participant to other household members within 28 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 4 Nov 2022.