[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coccidioidomycosis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coccidioidomycosis-infection":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100647593","phase-2-a-phase-ii-randomized-study-to-evaluate-measures-for-endpoint-derivation-in-patients-with-progressive-or-refractory-disseminated-coccidioidomycosis-dcm--treated-with-olorofim-plus-baseline-soc-or-placebo-plus-baseline-soc-100647593",false,"NCT07712484","A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care","COCCIMETRICS: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM) Treated With Olorofim Plus Baseline Standard of Care (SOC) or With Placebo Plus Baseline SOC","COCCIMETRICS","Inclusion Criteria:\n\n* Male and female patients, English- or Spanish-speaking, aged ≥18 years and weighing ≥40 kg.\n* Patients with progressive or refractory disseminated coccidioidomycosis (DCM) involving extra-pulmonary sites with or without ongoing active disease in lungs.\n* Standard of Care therapy for DCM to date has included 2 different triazoles (with or without a course of intravenous amphotericin B).\n\nExclusion Criteria:\n\n* Patients who are unconscious.\n* Women who are pregnant or breastfeeding.\n* Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.\n* Patients with or planned placement of indwelling CNS devices.\n* Patients receiving intrathecal amphotericin B at the time of study enrolment.\n* Coccidioidomycosis limited to fibro-cavitary pulmonary disease.\n* All bothersome DCM-related symptoms at study entry are due to irreversible damage (e.g., neurologic deficits due to stroke).\n* Other than cutaneous fungal infections treated topically and Pneumocystis jirovecii infections, patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis.\n* Patients with microbiological findings or other potential conditions that are temporally related and suggest a different than study indication etiology for the clinical features.\n* Patients living with Human immunodeficiency virus (HIV) unless for at least 6 months prior to enrollment:\n\n  1. Are receiving antiretroviral therapy AND\n  2. Have no evidence of current clinical progression resulting from HIV infection.\n* Patients who have received prior treatment with olorofim\u002FF901318.\n* Patients receiving treatment limited to supportive care due to predicted short survival time.\n* Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥500 msec, or at high risk for QT\u002FQTc prolongation.\n* Evidence of hepatic dysfunction.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated coccidioidomycosis (DCM).",[27,28,29,30,31,32,33,34],"Coccidioidomycosis","Disseminated Fungal Infection","Coccidioides Infection","Coccidioides Immitis Infection","Coccidioides Posadasii Infection","Coccidioidomycosis Infection","San Joaquin Valley Fever","Valley Fever",[36,27,37,38,34,39,40,41,42,43,44,45,46],"Cocci","Disseminated coccidioidomycosis","Olorofim","Patient-reported outcomes","Valley Fever Patient Reported Outcome","Symptom assessment","Endpoint development","Outcome measure validation","Quality of life","Fungal infection","Invasive fungal disease","NOT_YET_RECRUITING","2026-09-17",{"date":50,"type":51},"2026-09-22","ACTUAL",{"date":53,"type":21},"2026-12",{"date":55,"type":21},"2028-07",{"name":57,"class":58},"F2G Ltd","INDUSTRY"]