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
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
Prospective study participant, LAR and/or impartial witness (where applicable) declines to provide informed consent.
significant confusion or impaired consciousness (including unarousable coma)
multiple convulsions (more than two episodes within 24 hours),
respiratory distress
Parallel
Artemether lumefantrine tablets
DrugThere is no difference
Artemether Lumefantrine and Imatinib Mesylate
DrugThere is no difference
Dose of Imatinib (in mg) Required to Eliminate Viable Parasites
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.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity Grade
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.
Number of Participants with PCR-Corrected Recrudescence
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.
Change from Baseline in Parasite Density (parasites/μL)
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.
Change from Baseline in Body Temperature (°C)
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.
Percentage Reduction in Parasite Density from Baseline
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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Victoria Biomedical Research Institute
Lead sponsor
Purdue University
Collaborator
