Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria

Q: Who can participate in NCT07559370?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07559370?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria (NCT07559370) is a Phase 2 interventional studying Malaria (Plasmodium Falciparum), sponsored by Victoria Biomedical Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Malaria (Plasmodium Falciparum) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,116 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - Prospective study participant, LAR and/or impartial witness (where applicable) declines to provide willing to sign a consent form. - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 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. * Patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption. * Concomitant infection by plasmodium species other than P. falciparum * Inability to attend/meet study staff on follow up visits * Concomitant use of medicines, including: * medicines used to treat high cholesterol (such as atorvastatin, lovastatin, simvastatin); * medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine); * medicine used to treat HIV (antiretroviral medicines) including protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); * medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); * medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem; * medicines used to prevent/treat epileptic seizures including barbiturates (such as phenobarbital), carbamazepine or phenytoin; * medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus); * nefazodone (used to treat depression); * aprepitant (used to treat nausea);

Treatments Being Tested

DRUG

Artemether/lumefantrine tablets

There is no difference

DRUG

Artemether/Lumefantrine + Imatinib Mesylate

There is no difference

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Victoria Biomedical Research Institute

Kisumu, Kenya

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07559370), the sponsor (Victoria Biomedical Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07559370 clinical trial studying?

Who can participate in NCT07559370?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07559370?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07559370. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07559370. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.