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
Most antimalarial drugs work by directly attacking the Plasmodium falciparum parasite, but this approach carries a fundamental weakness: the parasite can slowly rewrite its own biology to shrug off these chemical assaults. Imatinib, a drug already proven safe in cancer treatment for over two decades, takes a radically different tack. Instead of targeting the invader, it targets the human red blood cell that the parasite infects. Specifically, Imatinib inhibits a human enzyme called Syk kinase a key that the parasite turns to pry open the cell and burst forth into the bloodstream. By jamming this lock, the drug traps the parasite inside the cell, where toxic byproducts accumulate and ultimately kill it. Because the parasite cannot alter human biology the way it alters its own, researchers believe resistance to Imatinib will be extraordinarily difficult if not impossible for malaria to evolve. To test this promising strategy, a clinical trial is now underway at the Alupe sub county hospital in Busia County, Kenya, a region bearing some of the nation's highest malaria burdens. The study unfolds in three cautious phases. First, between ninety and two hundred ten adults will receive varying doses of Imatinib starting at 400 milligrams twice daily to determine the safest regimen. If side effects prove too severe, the dose will be lowered to 600 or 400 milligrams once per day. Once the optimal dose is identified, the second phase will enroll 516 adults to confirm that adding Imatinib to the standard artemether lumefantrine (AL) regimen is as safe as AL alone, and to test whether a two day course works as well as the conventional three days. Finally, because children under five account for nearly eighty percent of malaria deaths, the third phase will extend the trial to younger participants from twelve months to seventeen years using weight based dosing. Participants who enroll must remain in the hospital for forty eight to seventy two hours of close observation. Medical staff will draw frequent blood samples, often via finger prick, to count parasites and monitor liver and kidney health. After discharge, patients return for follow up visits on days seven, twenty one, and thirty five to ensure the infection has not recurred. To compensate for time and lost wages, each participant receives 1,500 Kenyan shillings per day, and the study covers all travel and medical expenses. Safety is reinforced by clear boundaries. Although Imatinib is already FDA approved and widely used for cancer, its combination with AL is novel. To avoid dangerous drug interactions, anyone taking medications for high cholesterol, high blood pressure, or HIV cannot enroll. Pregnant or breastfeeding women are also excluded, as Imatinib can harm a developing fetus, and female participants must use birth control throughout the trial. The study operates under rigorous ethical oversight. It has been reviewed by the Jaramogi Oginga Odinga Teaching and Referral Hospital and the Pharmacy and Poisons Board, while an independent Data Safety Monitoring Board composed of doctors and scientists will continuously review the data to determine whether the trial remains safe to proceed. All participant information is protected under the Kenyan Data Protection Act, ensuring personal privacy is never compromised. Overall, the trial expects to enroll between 906 and 1,116 participants by the end of 2027, with the ultimate goal of delivering a more powerful, resistance proof tool for malaria elimination.
There is no difference
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Victoria Biomedical Research Institute
Kisumu, Kenya
RECRUITINGImatinib dose eliminating viable parasites after 2 days
Identification of imatinib dose that eliminates all viable parasites after 2 days of dosing, determined by absence of viable parasites on blood culture from samples taken immediately after 48 hours of study drug administration.
Time frame: 48 hours post-first dose
Number and severity of adverse events
Safety and tolerability of imatinib mesylate combined with artemether-lumefantrine (AL+IM) compared to artemether-lumefantrine alone (AL). Non-inferior safety defined as insignificant increase (p \> 0.05) in number and severity of adverse events in AL+IM cohorts versus AL alone.
Time frame: Up to Day 35
Rate of recrudescence at Day 35
Non-inferiority of 2-day AL+IM dosing compared to 3-day AL dosing as determined by PCR-corrected recrudescence using strain genotyping. Non-inferiority defined as insignificant increase (p \> 0.05) in recrudescence in 2-day AL+IM cohorts versus 3-day AL alone.
Time frame: Day 35
Parasite clearance rate
Accelerated parasite clearance of AL+IM compared to AL alone. Superior efficacy defined as significant decrease (p \< 0.05) in average parasite density in AL+IM cohorts versus AL cohort.
Time frame: Days 1, 2, and 3
Fever clearance time
Accelerated decrease in body temperature in AL+IM compared to AL alone. Superior efficacy defined as significant decrease (p \< 0.05) in elevated average body temperature in AL+IM cohorts versus AL cohort.
Time frame: Days 1, 2, and 3
Parasite clearance in high baseline parasitemia
Faster parasite clearance in participants with starting parasite density \>10,000 parasites/μL compared to those with \<10,001 parasites/μL in AL+IM cohorts. Defined as significant decrease (p \< 0.05) in percentage of parasites after first drug administration between high and low baseline density groups.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,116
Time frame: Days 1, 2, and 3