Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Recruiting now · Phase 2
Conditions studied: Malaria (Plasmodium Falciparum)
In brief
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
Key facts
- Study ID
- NCT07559370
- Run by
- Victoria Biomedical Research Institute
- People needed
- 1116
- Starts
- 2026-01-20
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-29
Who can join
Age: 1 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 hours),
- respiratory distress
- circulatory collapse (systolic blood pressure <80mm Hg with evidence of impaired perfusion)
- clinical jaundice plus evidence of other vital organ dysfunction
- simultaneous infection of unrelated origin
- Parasite density > 200,000 parasites /μl
- In the case of female participants: currently pregnant or lactating
- Other neurological or psychiatric symptoms or disorders
- Abnormal bleeding
- Resting heart rate lower than 55 or higher than 100 bpm
- History of cardiac disease
- Signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system
- Abnormal blood chemistry:
- hemoglobin < 9.0 g/dL in adults or < 5.0 g/dL in children 12 months-18 years
- WBC not in the range of 4800-10,000/mm3
- RBC if < 4.0x106/ mm3
- Platelet < 1.3x105/ mm3
- ALAT not in the normal range (4 to 36 U / l)
- ASAT not in the normal range (8 to 33 U / l)
- Total bilirubin 0.1 to 1.2 mg / 100 ml
- Serum protein if < 5.5 g/dL
- Symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.
Where it is running
- Victoria Biomedical Research Institute — Kisumu, Kenya (enrolling)
Full record on ClinicalTrials.gov
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