[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647765":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":22,"responsibleParty":30,"collaborators":22,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":22,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":22,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":58,"whyStopped":22,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":22},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Coartem® Baby (5mg\u002F60mg)","EXPERIMENTAL","Participants will receive Coartem® Baby at dose of 5mg\u002F60mg twice per day for 3 days.",[13],"Drug: Coartem® Baby",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Coartem® Baby","Coartem® Baby 2.5mg\u002F30mg oral dispersible tablets to be used at dose of 5mg\u002F60 mg twice per day for 3 days.",[9],[21],"Artemether: Lumefantrine",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Novartis Pharmaceuticals","CONTACT","+41613241111","novartis.email@novartis.com",{"name":25,"role":26,"phone":22,"phoneExt":22,"email":22},{"type":31,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100647765","phase-4-study-to-assess-safety-and-clinical-responses-with-coartem-baby-dispersible-tablets-in-paediatric-patients-weighing-2-to-5-kg-with-uncomplicated-malaria-100647765",false,"NCT07713602","Study to Assess Safety and Clinical Responses With Coartem® Baby Dispersible Tablets in Paediatric Patients Weighing 2 to \u003C5 kg With Uncomplicated Malaria","A Multi-centre, Open-label, Non-comparative Study to Assess Safety and Clinical Response With Coartem® Baby Dispersible Tablets in Paediatric Patients (≥ 2 to \u003C5 kg) With Uncomplicated Malaria Due to Plasmodium Falciparum or Mixed Infections","Key Inclusion Criteria:\n\n* Male or female neonates\u002Finfants\n* Body weight ≥ 2 kg to \\\u003C 5kg\n* Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy.\n* Eligible to receive Coartem® Baby dispersible tablets as per approved label\n\nKey Exclusion Criteria:\n\nParticipants with Coartem® Baby contraindications as per approved label.\n\n* Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby.\n* Patients with severe malaria according to WHO definition (See Appendix 3).\n* Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.\n* Patients taking drugs that are known to prolong the QTc interval\n* Any additional contraindications as per the approved label in the country","ALL","0 Days","12 Months",{"count":43,"type":44},20,"ESTIMATED","INTERVENTIONAL",[47],"PHASE4","This study is being conducted to further evaluate the safety and clinical outcomes of Coartem® Baby (artemether\u002Flumefantrine 5 mg\u002F60 mg) in neonates and infants weighing ≥2 kg to \\\u003C5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.",[50],"Malaria",[52,53,17,54,55,56,57],"Safety","clinical outcome","infant","neonates","body weight ≥ 2 to \u003C5 kg","uncomplicated malaria","NOT_YET_RECRUITING","2026-07-14",{"date":61,"type":62},"2026-07-20","ACTUAL",{"date":64,"type":44},"2027-06-18",{"date":66,"type":44},"2028-05-31",{"name":25,"class":6}]