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Tests treatment safety and results for Malaria (Plasmodium Falciparum)
Official title Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
ClinicalTrials.gov ID: NCT07559370
What this study is testing
What is Artemether lumefantrine tablets?
Artemether lumefantrine tablets is an investigational medicine, given as an once-daily, being studied as a potential treatment for malaria (plasmodium falciparum).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 55
You may be able to join if
- For Part 1 and 2 of the study design, all individuals must meet all the 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...
- Provision of informed consent and agrees to hospital admission for 48-72hrs
- Good health condition other than malaria
You likely can't join 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)
See the full eligibility criteria
- For Part 1 and 2 of the study design, all individuals must meet all the 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 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.
- 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...
- 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);
The study team makes the final eligibility decision.
Where it's taking place
- Kisumu, Kenya
Compensation & support
Some study costs may be covered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kisumu, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.