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Recruiting NCT07559370

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

Conditions: Malaria (Plasmodium Falciparum)

Sex: All
Ages: 1 Year – 55 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 1116
Sponsor: Victoria Biomedical Research Institute

Location: Victoria Biomedical Research Institute Kisumu

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 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 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 \ 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);

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07559370). StuddyBuddy aggregates publicly available trial information.