[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100388692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":62,"collaborators":42,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":42,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":42,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universitas Padjadjaran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexamethasone","ACTIVE_COMPARATOR","Sixty nine patients will be administered randomly dexamethasone 20 mg IV for 7 days.\n\nAlong with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.",[13],"Drug: Dexamethasone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sixty nine patients will be administered randomly Normal Saline 0,9% IV (4 cc) for 7 days.\n\nAlong with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days",[9],[26],"Dexamethasone - Phapros",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Patients in placebo arms will receive 20 mL normal saline intravenously for 7 days",[15],[31],"Normal Saline 0,9% - B Braun",[33],{"name":34,"affiliation":35,"role":36},"Sofiati Dian, M.D., PhD","Faculty of Medicine Universitas Padjadjaran Bandung","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Ahmad R Ganiem, M.D., PhD","CONTACT","+62 878 2288 3773",null,"rizalbdg@gmail.com",{"name":34,"role":40,"phone":45,"phoneExt":42,"email":46},"+62 812 2119 519","sofiatidian@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":42},"Hasan Sadikin General Hospital","RECRUITING","Bandung","West Java","40161","Indonesia","ID",{"type":57,"coordinates":58},"Point",[59,60],107.60694,-6.92222,{"lat":60,"lon":59},{"type":63,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100388692","phase-2-dexamethasone-for-cerebral-toxoplasmosis-100388692",false,"NCT04341155","Dexamethasone for Cerebral Toxoplasmosis","Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial","De-Tox","Inclusion Criteria:\n\n1. Age 18 years or above.\n2. Clinical signs and symptoms compatible to cerebral toxoplasmosis\n3. Serology HIV positive\n4. Immunoglobulin G anti-toxoplasma titre is positive\n5. One or more mass lesions on the neuroradiological finding\n6. None or less than 3 days of dexamethasone therapy taken\n7. Written informed consent from the patients or from close relatives of the patient if the patient is unconscious.\n\nExclusion Criteria:\n\n1. History of anti-toxoplasmosis administrattion for more than 5 days before recruitment\n2. Hypersensitivity or other contraindication to dexamethasone\n3. Pregnancy","ALL","18 Years",{"count":75,"type":76},138,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Toxoplasma gondii infects over one third of the global human population. Cerebral toxoplasmosis is the most common opportunistic infection in HIV patients resulting in up to 50% of mortality with proper treatment and 80% without it. The fatality mainly due to the brain edema resulted from the mass effect lesion. In addition of anti toxoplasmosis given, adjunctive therapy such as steroid is recommended in order to reduce brain edema, but the dose and duration of administration in cerebral toxoplasmosis has not been evaluated in a clinical trial. Adjunctive therapy given in cerebral toxoplasmosis patients still remains unclear. Moreover, its safety in immunodeficiency cases is still debatable.",[82],"Toxoplasmosis, Cerebral","2024-07-02",{"date":85,"type":86},"2024-07-03","ACTUAL",{"date":88,"type":86},"2021-04-16",{"date":90,"type":76},"2025-07",{"name":5,"class":6},1]