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

Exclusion Criteria38

• 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);