Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Mal… (NCT07559370) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Kenya1,116 participantsStarted 2026-01-20
Plain-language summary
This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa
Who can participate
Age range
1 Year – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:
* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of \>= 5000 parasites/μl
* Adult male, age 18-55 years old or adult female, age 18-55 years that are post-menopausal, or test negative on a pregnancy test and will be on active birth control through to the end of the follow up period.
* Provision of informed consent and agrees to hospital admission for 48-72hrs
* Good health condition other than malaria
* The patient has not taken anti-malarial drugs in the past 4 weeks
For Part 3 of the trial, all individuals must meet all the inclusion criteria below:
* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of \>= 5000 parasites/μl
* Age 12 months to below 18 years
* Presented by parent or legally accepted representative (LAR) who has consented to the participation of the child in the trial and agrees to hospital admission for 48-72hrs.
* Hb levels \> 5mg/dL
* Child has not taken anti-malarial drugs in the past 6 weeks.
Exclusion Criteria:
* Prospective study participant, LAR and/or impartial witness (where applicable) declines to provide informed consent.
* Symptoms and signs of severe or complicated malaria including:
* significant confusion or impaired consciousness (including unarousable coma)
* multiple convulsions (more than two episodes within 24 ho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose of Imatinib (in mg) Required to Eliminate Viable Parasites
Timeframe: 48 hours post-first dose
2
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity Grade
Timeframe: Up to Day 35
3
Number of Participants with PCR-Corrected Recrudescence