[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Victoria Biomedical Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100635952","phase-2-safety-and-efficacy-of-imatinib-in-combination-with-artemether-lumefantrine-for-uncomplicated-malaria-100635952",false,"NCT07559370","Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria","Evaluating the Safety and Efficacy of Imatinib in Combination With Artemether and Lumefantrine for Treatment of Uncomplicated Malaria","Inclusion Criteria:\n\nFor Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of \\>= 5000 parasites\u002Fμl\n* 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.\n* Provision of informed consent and agrees to hospital admission for 48-72hrs\n* Good health condition other than malaria\n* The patient has not taken anti-malarial drugs in the past 4 weeks\n\nFor Part 3 of the trial, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of \\>= 5000 parasites\u002Fμl\n* Age 12 months to below 18 years\n* 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.\n* Hb levels \\> 5mg\u002FdL\n* Child has not taken anti-malarial drugs in the past 6 weeks.\n\nExclusion Criteria:\n\n* Prospective study participant, LAR and\u002For impartial witness (where applicable) declines to provide informed consent.\n* Symptoms and signs of severe or complicated malaria including:\n\n  * significant confusion or impaired consciousness (including unarousable coma)\n  * multiple convulsions (more than two episodes within 24 hours),\n  * respiratory distress\n  * circulatory collapse (systolic blood pressure \\\u003C80mm Hg with evidence of impaired perfusion)\n  * clinical jaundice plus evidence of other vital organ dysfunction\n  * simultaneous infection of unrelated origin\n* Parasite density \\> 200,000 parasites \u002Fμl\n* In the case of female participants: currently pregnant or lactating\n* Other neurological or psychiatric symptoms or disorders\n* Abnormal bleeding\n* Resting heart rate lower than 55 or higher than 100 bpm\n* History of cardiac disease\n* Signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system\n* Abnormal blood chemistry:\n\n  * hemoglobin \\\u003C 9.0 g\u002FdL in adults or \\\u003C 5.0 g\u002FdL in children 12 months-18 years\n  * WBC not in the range of 4800-10,000\u002Fmm3\n  * RBC if \\\u003C 4.0x106\u002F mm3\n  * Platelet \\\u003C 1.3x105\u002F mm3\n  * ALAT not in the normal range (4 to 36 U \u002F l)\n  * ASAT not in the normal range (8 to 33 U \u002F l)\n  * Total bilirubin 0.1 to 1.2 mg \u002F 100 ml\n  * Serum protein if \\\u003C 5.5 g\u002FdL\n* Symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.\n* Patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption.\n* Concomitant infection by plasmodium species other than P. falciparum\n* Inability to attend\u002Fmeet study staff on follow up visits\n* Concomitant use of medicines, including:\n\n  * medicines used to treat high cholesterol (such as atorvastatin, lovastatin, simvastatin);\n  * medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);\n  * 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);\n  * medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);\n  * medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;\n  * medicines used to prevent\u002Ftreat epileptic seizures including barbiturates (such as phenobarbital), carbamazepine or phenytoin;\n  * medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);\n  * nefazodone (used to treat depression);\n  * aprepitant (used to treat nausea);","ALL","1 Year","55 Years",{"count":20,"type":21},1116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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",[27],"Malaria (Plasmodium Falciparum)",[29,30,31,32,33],"Uncomplicated malaria","Artemether-lumefantrine (AL) combination therapy","Imatinib mesylate","Drug-resistant malaria","Parasite egress blockade","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2026-01-20",{"date":42,"type":21},"2027-06-30",{"name":44,"class":45},"Victoria Biomedical Research Institute","OTHER",""]