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 range1 Year – 55 Years
SexALL
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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…
What they're measuring
1
Imatinib dose eliminating viable parasites after 2 days