[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100168288":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":26,"responsibleParty":38,"collaborators":40,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Jomaa Pharma GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fosmidomycin-Clindamycin","EXPERIMENTAL","Single arm study. Co-administration of Fosmidomycin and Clindamycin.",[13],"Drug: Fosmidomycin and Clindamycin co-administration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Fosmidomycin and Clindamycin co-administration","Fosmidomycin sodium syrup at a concentration of 250mg\u002F5ml and clindamycin hydrochloride syrup at a concentration of 75mg\u002F5ml. Administered in doses of fosmidomycin 30mg\u002Fkg\u002Fdose + clindamycin 10mg\u002Fkg\u002Fdose twice daily for three days (total daily dose fosmidomycin 60mg\u002Fkg, clindamycin 20mg\u002Fkg)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Quique Bassat, PhD","CRESIB, Barcelona","PRINCIPAL_INVESTIGATOR",[27],{"facility":28,"status":20,"city":29,"state":20,"zip":20,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":20},"Centro de Investigacao em Saude da Manhica","Maputo","Mozambique","MZ",{"type":33,"coordinates":34},"Point",[35,36],32.58322,-25.96553,{"lat":36,"lon":35},{"type":39,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[41,44],{"name":42,"class":43},"Fundacio Clinic Barcelona","OTHER",{"name":45,"class":43},"Hospital Clinic of Barcelona","100168288","phase-2-evaluation-of-fosmidomycin-and-clindamycin-in-the-treatment-of-acute-uncomplicated-pfalciparum-malaria-in-children-100168288",false,"NCT01464138","Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children","Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children","Inclusion Criteria:\n\n* Male subjects aged six months to three years\n* Female subjects aged six months to three years\n* Body weight \\>5kg\n* Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria\n* Asexual parasitaemia between 1,000\u002FµL and 200,000\u002FµL\n* Ability to tolerate oral therapy\n* Willingness of the parent or guardian to provide informed signed consent\n\nExclusion Criteria:\n\n* Symptoms\u002Fsigns of severe malaria, according to WHO criteria\n* Body weight \\\u003C5kg\n* Other plasmodial infections (P vivax, P ovale, P malariae)\n* Severe malnutrition with weight for age \\\u003C60% or clinical kwashiorkor\n* Gastro-intestinal disturbance with persistent vomiting (\\> three episodes within previous 24 hours) and\u002For diarrhoea (\\> 5 loose stools in the preceding 24 hours)\n* Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment\n* Haemoglobin \\\u003C7g\u002Fdl\n* Adequate anti-malarial treatment within previous 7 days\n* Inability to tolerate oral therapy\n* Parent or guardian deemed to be unsupportive\n* On co-trimoxazole prophylaxis","ALL","6 Months","3 Years",{"count":57,"type":58},52,"ACTUAL","INTERVENTIONAL",[61],"PHASE2","This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.\n\nThe primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.",[64],"Malaria",[64],"COMPLETED","2011-11-02",{"date":69,"type":70},"2011-11-03","ESTIMATED",{"date":72,"type":20},"2010-09",{"date":74,"type":58},"2011-09",{"name":5,"class":6},1]