[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567294":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":58,"centralContacts":65,"locations":71,"responsibleParty":100,"collaborators":102,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":41,"enrollmentInfo":115,"targetDuration":41,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":41,"overallStatus":74,"whyStopped":41,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","randomized to standard of care",[13],"Drug: Standard of care",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental group 1","EXPERIMENTAL","randomized to experimental antifungal therapy #1",[19],"Drug: Oteseconazole - antifungal therapy 1",{"label":21,"type":16,"description":22,"interventionNames":23},"Experimental group 2","randomized to experimental antifungal therapy #2",[24],"Drug: Turletricin injection - antifungal therapy 2",{"label":26,"type":16,"description":27,"interventionNames":28},"Experimental group 3","randomized to experimental antifungal therapy #3",[29],"Drug: Turletricin Injection - antifungal therapy 3",{"label":31,"type":16,"description":32,"interventionNames":33},"Experimental group 4","randomized to experimental antifungal therapy #4",[34],"Drug: Oteseconazole with Flucytosine - antifungal therapy 4",[36,42,46,50,54],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Standard of care","2022 WHO First Line Induction Therapy:\n\n1. Liposomal Amphotericin B 10mg\u002Fkg IV given once\n2. Flucytosine 100mg\u002Fkg\u002Fday for 14 days in divided doses\n3. Fluconazole 1200mg\u002Fday for 14 days Consolidation Therapy: Fluconazole 800mg\u002Fday from 2 to 10 weeks Secondary Prophylaxis: Fluconazole 200mg\u002Fday through 1 year minimum",[9],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Oteseconazole - antifungal therapy 1","Oteseconazole, is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51)\n\n* Loading doses of oral Oteseconazole 600 mg twice daily for 10 days, then 600 mg oteseconazole weekly on weeks 3, 4, 5, and 6.\n* Liposomal Amphotericin B 10 mg\u002Fkg IV once.\n* No fluconazole or 5FC to be given.",[15],{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Turletricin injection - antifungal therapy 2","SF001 2.0 mg\u002Fkg IV administered on day 1, followed by 1.5 mg\u002Fkg on day 8 with Fluconazole 1200mg\u002Fday and flucytosine 100mg\u002Fday in divided doses x 14 days",[21],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":41},"Turletricin Injection - antifungal therapy 3","SF001 3.0 mg\u002Fkg IV administered on day 1, 8, and 15 with fluconazole 1200mg\u002Fday and flucytosine 100mg\u002Fday in divided doses x 14 days",[26],{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":41},"Oteseconazole with Flucytosine - antifungal therapy 4","Oteseconazole, is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51) ● Loading doses of oral Oteseconazole 600 mg twice daily for 12 days, then 600 mg oteseconazole weekly on weeks 3 to 12. ● Liposomal Amphotericin B 10 mg\u002Fkg IV once. ● Flucytosine 100mg\u002Fkg given for 7 days.",[31],[59,62],{"name":60,"affiliation":5,"role":61},"David R Boulware, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":63,"affiliation":64,"role":61},"David B Meya, MBChB, MMed, PhD","Uganda",[66],{"name":67,"role":68,"phone":69,"phoneExt":41,"email":70},"David Boulware, MD, MPH","CONTACT","612-624-9996","coat.trial@gmail.com",[72,87],{"facility":73,"status":74,"city":75,"state":41,"zip":41,"country":64,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Infectious Diseases Institute","RECRUITING","Kampala","UG",{"type":78,"coordinates":79},"Point",[80,81],32.58219,0.31628,{"lat":81,"lon":80},[84],{"name":85,"role":68,"phone":41,"phoneExt":41,"email":86},"David Meya, PhD","david.meya@gmail.com",{"facility":88,"status":74,"city":89,"state":41,"zip":41,"country":64,"countryCode":76,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Mbarara University of Science and Technology","Mbarara",{"type":78,"coordinates":91},[92,93],30.64851,-0.60467,{"lat":93,"lon":92},[96],{"name":97,"role":68,"phone":98,"phoneExt":41,"email":99},"Conrad Muzoora","256772547175","conradmuzoora@gmail.com",{"type":101,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[103],{"name":73,"class":104},"UNKNOWN","100567294","phase-2-platform-trial-for-cryptococcal-meningitis-platform-cm-100567294",false,"NCT06666322","Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)","Platform Trial For Cryptococcal Meningitis","PLATFORM-CM","Inclusion Criteria:\n\n* CSF cryptococcal antigen (CrAg) positive meningitis\n* Living with HIV\n* Ability and willingness to provide informed consent\n* Willing to receive protocol-specified lumbar punctures\n* Age \\>= 18 years\n* Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).\n\nExclusion Criteria:\n\n* Received 3 or more doses of antifungal therapy for meningitis within last 30 days\n* Inability to take enteral (oral or nasogastric) medicine\n* Cannot or unlikely to attend regular clinic visits\n* Receiving chemotherapy or corticosteroids\n* Receiving hemodialysis or known liver cirrhosis\n* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)\n* Pregnancy or breastfeeding\n* Previous administration of investigational study drug\n* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments\n* Trial Appendix study-drug specific eligibility criteria","ALL","18 Years",{"count":116,"type":117},2000,"ESTIMATED","INTERVENTIONAL",[120,121],"PHASE2","PHASE3","Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV\u002FAIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.",[124,125],"Hiv","Cryptococcal Meningitis","2026-06-17",{"date":128,"type":129},"2026-06-22","ACTUAL",{"date":131,"type":129},"2025-05-28",{"date":133,"type":117},"2032-04-21",{"name":5,"class":6},2]