[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uncomplicated-plasmodium-falciparum-malaria\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uncomplicated-plasmodium-falciparum-malaria":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"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":46},"100512372","phase-3-a-study-to-find-out-if-a-combination-of-3-medicines-for-the-treatment-of-malaria-works-as-well-and-is-as-safe-and-tolerable-as-combinations-of-2-medicines-100512372",false,"NCT05951595","A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines","An Open-label, Randomised, Controlled, Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of a Fixed Dose Triple Artemisinin-based Combination Therapy (TACT) Artemether-lumefantrine-amodiaquine Versus First-line Artemisinin-based Combination Therapies (ACTs) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria","FD-TACT","Inclusion Criteria:\n\n* Male or female, aged ≥6 months (no upper limit unless one is required by local regulations) and bodyweight ≥5 kg\n* Ability to take oral medication\n* Fever defined as ≥38°C tympanic temperature or a history of fever within the last 24 hours\n* Acute uncomplicated P. falciparum monoinfection\n* Asexual P. falciparum parasitaemia: 1,000\u002FµL to 250,000\u002FµL determined on a peripheral blood film\n* Written informed consent by the participant, or by the parent\u002Fguardian in case of children lower than the age of consent, and assent if required (per local regulations)\n* Willingness and ability of the participants or parents\u002Fguardians to comply with the study protocol for the duration of the study\n\nExclusion Criteria:\n\n* Signs of severe malaria (adapted from WHO criteria)\n* Patients not fulfilling criteria for severe malaria but with other indication(s) for parenteral antimalarial treatment at the discretion of the treating physician\n* Haemoglobin \\\u003C7 g\u002FdL at screening\n* Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days\n* In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days\n* Acute illness other than malaria requiring systemic treatment\n* Severe acute malnutrition\n* Known HIV, tuberculosis, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or other severe infection\n* For women of child-bearing age: pregnant, trying to get pregnant or lactating\n* History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy\n* Previous splenectomy\n* Participation in the previous 3 months and\u002For ongoing follow-up for an interventional study (including FD-TACT)","ALL","6 Months",{"count":20,"type":21},1680,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this open-label randomised, controlled, non-inferiority trial is to assess and compare the efficacy, tolerability and safety of a fixed dose TACT artemether-lumefantrine-amodiaquine (ALAQ) to the ACTs artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) (with single low-dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria in patient. The main question it aims to answer is whether ALAQ, a fixed dose TACT, is as efficacious, safe and tolerable in comparison with AL and ASAQ.\n\nParticipants will be enrolled, admitted and randomised to receive the study drug (ALAQ, AL or ASAQ). Patients will receive directly observed treatments and will be followed up at least once daily for the first 3 days after enrolment followed by weekly visits from D7 up to D42. Patients will be asked to report to the clinics between scheduled visits in case of any illness or other symptoms or complaints.",[27],"Uncomplicated Plasmodium Falciparum Malaria",[29,30,31,32,33],"Artemether","Lumefantrine","Amodiaquine","Artesunate","Triple Artemisinin-based Combination Therapy (TACT)","RECRUITING","2025-11-14",{"date":37,"type":38},"2025-11-18","ACTUAL",{"date":40,"type":38},"2025-09-11",{"date":42,"type":21},"2026-07-31",{"name":44,"class":45},"University of Oxford","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100496929","phase-2-platform-study-to-evaluate-the-efficacy-and-safety-of-anti-malarial-agents-in-patients-with-uncomplicated-plasmodium-falciparum-malaria-100496929","NCT05750628","Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria","A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and\u002For Combination Therapy IN Patients With Uncomplicated Plasmodium Falciparum Malaria","PLATINUM","Inclusion Criteria:\n\n1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to \\\u003C12 years of age for Part C at screening.\n2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count\u002Fμl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual parasite count\u002Fμl of blood for Parts B and C.\n3. Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 kg at screening.\n4. Axillary temperature ≥ 37.5ºC or oral\u002Ftympanic\u002Frectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.\n\nExclusion Criteria:\n\n1. Patients with signs and symptoms of severe\u002Fcomplicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening\n2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \\\u003C 8 g\u002FdL), or known chronic underlying disease such as sickle cell disease at screening\n3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:\n\n   * AST\u002FALT \\> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin\n   * AST\u002FALT \\> 1.5 and ≤ 2 x ULN and total bilirubin is \\> ULN\n   * Total bilirubin \\> 2 x ULN, regardless of the level of AST\u002FALT\n4. Any known\u002Fsuspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.\n5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.\n6. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:\n\n   * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n   * History of familial long QT syndrome or known family history of Torsades de Pointe.\n   * Resting heart rate (physical exam or 12 lead ECG) \\\u003C 50 bpm\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","2 Years","100 Years",{"count":58,"type":21},327,[60],"PHASE2","Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria",[27],[64,65,66,67,53],"malaria","uncomplicated malaria","Plasmodium falciparum","platform study","2025-07-29",{"date":70,"type":38},"2025-07-30",{"date":72,"type":38},"2024-01-23",{"date":74,"type":21},"2026-06-23",{"name":76,"class":77},"Novartis Pharmaceuticals","INDUSTRY",12]