Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
Recruiting
Phase 2Interventional Study
Malaria (Plasmodium Falciparum)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 – 55
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
1,116 (estimated)
Sponsor
Victoria Biomedical Research Institute · Other
Who this trial is looking for
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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
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Eligibility Criteria
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…
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);
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