[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635952":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":87,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":38,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":38,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":58,"whyStopped":38,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Victoria Biomedical Research Institute","OTHER",[8,14,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Artemether Lumefantrine Alone","ACTIVE_COMPARATOR","Standard 3-day course. Used as control in all parts.",[13],"Drug: Artemether lumefantrine tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Artemether Lumefantrine and Imatinib 400mg Twice Daily (3 days)","EXPERIMENTAL","3-day course with imatinib 400mg twice daily.",[19],"Drug: Artemether Lumefantrine and Imatinib Mesylate",{"label":21,"type":16,"description":22,"interventionNames":23},"Artemether Lumefantrine and Imatinib (Optimal Dose, 3 days)","3-day course with optimal dose determined from Part 1.",[19],{"label":25,"type":16,"description":26,"interventionNames":27},"Artemether Lumefantrine and Imatinib (Optimal Dose, 2 days)","2-day imatinib course (optimal dose) with 3-day AL.",[19],{"label":29,"type":16,"description":30,"interventionNames":31},"Pediatric: Artemether Lumefantrine and Imatinib (Weight-based)","Weight-based imatinib (340 or 260 mg\u002Fm²\u002Fday, max 600mg) plus weight-based AL for 3 days.",[19],[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Artemether lumefantrine tablets","There is no difference",[9],null,{"type":34,"name":40,"description":36,"armGroupLabels":41,"otherNames":38},"Artemether Lumefantrine and Imatinib Mesylate",[25,21,15,29],[43],{"name":44,"affiliation":5,"role":45},"Dr. Quentin Awori MBChB","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":38,"email":51},"Dr. Quentin Awori, MBChB","CONTACT","+254722913616","qawori@vibriafrica.org",{"name":53,"role":49,"phone":54,"phoneExt":38,"email":55},"David Owino Ogolla, Msc","+254714421248","dogolla@vibriafrica.org",[57],{"facility":5,"status":58,"city":59,"state":38,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Kisumu","40100","Kenya","KE",{"type":64,"coordinates":65},"Point",[66,67],34.76171,-0.10221,{"lat":67,"lon":66},[70,74,75,76,79,81,83,85],{"name":71,"role":49,"phone":72,"phoneExt":38,"email":73},"Dr. Diana Odhiambo Irene, MBChB","+254722243110","dodhiambo@vibriafrica.org",{"name":53,"role":49,"phone":54,"phoneExt":38,"email":55},{"name":44,"role":45,"phone":38,"phoneExt":38,"email":38},{"name":77,"role":78,"phone":38,"phoneExt":38,"email":38},"Dr. Lucas Otieno Tina, MBChB","SUB_INVESTIGATOR",{"name":80,"role":78,"phone":38,"phoneExt":38,"email":38},"Dr. Diana Irene Odhiambo, MBChB",{"name":82,"role":45,"phone":38,"phoneExt":38,"email":38},"Dr. Karson Putt Phd",{"name":84,"role":78,"phone":38,"phoneExt":38,"email":38},"Dr. Simon Kariuki Phd",{"name":86,"role":78,"phone":38,"phoneExt":38,"email":38},"Dr Antony Oindo MBChB",{"type":45,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Quentin Awori","Principal Investigator",[91],{"name":92,"class":6},"Purdue University","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":104,"type":105},1116,"ESTIMATED","INTERVENTIONAL",[108],"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",[111],"Malaria (Plasmodium Falciparum)",[113,114,115,116,117],"Uncomplicated malaria","Artemether-lumefantrine (AL) combination therapy","Imatinib mesylate","Drug-resistant malaria","Parasite egress blockade","2026-06-24",{"date":120,"type":121},"2026-06-29","ACTUAL",{"date":123,"type":121},"2026-01-20",{"date":125,"type":105},"2027-06-30",{"name":5,"class":6},1]