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Evaluating the Safety and Efficacy of Imatinib in Combination With Artemether and Lumefantrine for Treatment of Uncomplicated Malaria

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 55
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Kenya
Victoria Biomedical Research Institute
RECRUITING
Kisumu
Contact Information
Primary
Dr. Quentin Awori, MBChB
qawori@vibriafrica.org
+254722913616
Backup
David Ogolla Awori, Msc
dogolla@vibriafrica.org
+254714421248
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 1116
Treatments
Active_comparator: AL Alone
Standard 3-day course. Used as control in all parts.
Experimental: AL + Imatinib 400mg Twice Daily (3 days)
3-day course with imatinib 400mg twice daily.
Experimental: AL + Imatinib (Optimal Dose, 3 days)
3-day course with optimal dose determined from Part 1.
Experimental: AL + Imatinib (Optimal Dose, 2 days)
2-day imatinib course (optimal dose) with 3-day AL.
Experimental: Pediatric: AL + Imatinib (Weight-based)
Weight-based imatinib (340 or 260 mg/m²/day, max 600mg) plus weight-based AL for 3 days.
Related Therapeutic Areas
Sponsors
Leads: Victoria Biomedical Research Institute

This content was sourced from clinicaltrials.gov

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