[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100252347":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":36,"centralContacts":31,"locations":31,"responsibleParty":41,"collaborators":31,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":31,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":31,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":31,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":31},{"fullName":5,"class":6},"University of Yaounde 1","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"ARTES","ACTIVE_COMPARATOR","* Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter.\n* Patients received 2.4 mg\u002Fkg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours.\n* Patients exited from the protocol if they had clinically recovered and parasitaemia was negative.",[13],"Drug: Artesunate",{"label":15,"type":10,"description":16,"interventionNames":17},"QLD","* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received a loading dose of 16.6 mg\u002Fkg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg\u002Fkg bw over 4 hours every 8 hours diluted in 10 ml\u002Fkg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.",[18],"Drug: Quinine",{"label":20,"type":10,"description":21,"interventionNames":22},"QNLD3","* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received 8.3 mg\u002Fkg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml\u002Fkg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.",[18],{"label":24,"type":10,"description":25,"interventionNames":26},"QNLD2","* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received 12.5 mg\u002Fkg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml\u002Fkg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.",[18],[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":31},"DRUG","Artesunate",null,[9],{"type":29,"name":34,"description":31,"armGroupLabels":35,"otherNames":31},"Quinine",[15,24,20],[37],{"name":38,"affiliation":39,"role":40},"Elie MBONDA","Faculty of Medicine and Biomedical Sciences, University of Yaounde I","STUDY_DIRECTOR",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","ETHE MAKA Daniel","MD","100252347","phase-3-a-trial-of-the-efficacy-of-artesunate-and-three-quinine-regimens-in-the-treatment-of-severe-malaria-in-children-at-the-ebolowa-regional-hospital---cameroon-100252347",false,"NCT02563704","A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon","A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon","Inclusion Criteria:\n\n* Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)\n* and having an initial positive parasitaemia to Plasmodium falciparum\n* Other aetiologies of the presenting symptoms excluded\n* Written consent from parent(s)\n\nExclusion Criteria:\n\n* Prior side effects to either artesunate or quinine administration\n* Severely malnourished children\n* Concomitant infection","ALL","3 Months","15 Years",{"count":56,"type":57},238,"ACTUAL","INTERVENTIONAL",[60],"PHASE3","The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon",[63],"Malaria",[30,34,65,63,66,67],"Efficacy","Children","Cameroon","COMPLETED","2015-09-30",{"date":71,"type":72},"2015-10-01","ESTIMATED",{"date":74,"type":31},"2013-09",{"date":76,"type":57},"2014-03",{"name":5,"class":6}]