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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Jackson Mukonzo, PhD contact

+256758113468

mukojack@yahoo.co.uk

Patrick Chelangat, Msc contact

+256704086766

chelapato25@gmail.com

Uganda1 site, 1 recruiting
  • ST. Paul's Health Center

    Kasese

    Peter Muhindo

    Recruiting

Other trials in Uganda

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 groups in NCT05605925
Study groupRoleWhat they receive
Control armActive comparator4 tabs artemether/lumefantrine 20/120mg, twice daily for 3 days
Receives: Drug: Artemether/lumefantrine
Intervention armExperimentalIVN 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.

  1. 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)
  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.

  1. First posted4 Nov 2022
  2. Study start4 Aug 2022
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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)
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

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.

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