[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100094698":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":11,"locations":38,"responsibleParty":50,"collaborators":53,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm 1","EXPERIMENTAL",null,[13],"Drug: Artesunate",{"label":15,"type":16,"description":11,"interventionNames":17},"arm 2","ACTIVE_COMPARATOR",[18],"Drug: Artesunate + Mefloquine",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Artesunate","Artesunate 2 mg\u002Fkg\u002Fday for 7 days",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Artesunate + Mefloquine","Artesunate 4mg\u002Fkg\u002Fday for 3 days plus mefloquine 15mg\u002Fkg on day 3 and 10mg\u002Fkg on day 4",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Nicholas J White, DSc,FRCP,FRS","Oxford University\u002F Mahidol University","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":37},"Duong Socheat, MD","National Malaria Control Programme Cambodia","STUDY_CHAIR",[39],{"facility":40,"status":11,"city":41,"state":11,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Pailin Referal Hospital","Pailin","Cambodia","KH",{"type":45,"coordinates":46},"Point",[47,48],102.60928,12.84895,{"lat":48,"lon":47},{"type":33,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Arjen Dondorp","Deputy Director",[54,56,58,60,63,65],{"name":55,"class":6},"World Health Organization",{"name":57,"class":6},"NCHADS - Ministry of Health of Cambodia",{"name":59,"class":6},"Mahidol University",{"name":61,"class":62},"Institut Pasteur","INDUSTRY",{"name":64,"class":6},"FHI 360",{"name":66,"class":6},"Li Ka Shing Foundation","100094698","clinical-investigation-of-in-vivo-susceptibility-of-pfalciparum-to-artesunate-in-western-cambodia-100094698",false,"NCT00493363","Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia","Inclusion Criteria:\n\n* Children \\>5yrs and adults presenting with acute falciparum malaria (N=40) to Pailin hospital will be eligible for inclusion in this study provided that\n\n  * They or their parents\u002Fguardians give fully informed consent.\n  * They are not pregnant.\n  * They have not received antimalarial drugs in the previous 48 hours.\n  * P.falciparum parasitaemia exceeds 10,000\u002FuL\n\nExclusion Criteria:\n\n* Mixed infection (such as vivax malaria), history of allergy to artesunate or mefloquine, any sign of severe disease according to WHO criteria","ALL","6 Years",{"count":76,"type":77},40,"ACTUAL","INTERVENTIONAL",[80],"NA","There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics.\n\nThe primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia.\n\nA detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg\u002Fkg\u002Fday for 7 days or b) Artesunate 4mg\u002Fkg\u002Fday for 3 days plus mefloquine 15mg\u002Fkg on day 3 and 10mg\u002Fkg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').",[83],"Falciparum Malaria",[85,86,87,88],"falciparum malaria","artemisinins","artesunate","resistance","COMPLETED","2018-05-01",{"date":92,"type":77},"2018-05-04",{"date":94,"type":11},"2007-06",{"date":96,"type":77},"2009-12",{"name":5,"class":6},1]