[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"candidemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:candidemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100471667","phase-3-a-phase-3-efficacy-and-safety-study-of-fosmanogepix-for-the-treatment-of-adult-participants-with-candidemia-andor-invasive-candidiasis-100471667",false,"NCT05421858","A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and\u002For Invasive Candidiasis.","An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and\u002For Invasive Candidiasis","Inclusion Criteria:\n\n1. Patients ≥ 18 years (or the minimum country-specific age of consent if \\> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself\u002Fherself, a legally authorized representative must provide informed consent on his\u002Fher behalf.\n2. Diagnosis of candidemia and\u002For invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia\u002Finvasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.\n3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.\n\nExclusion Criteria:\n\n1. Existing infection\n\n   1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.\n   2. Inappropriate fungal infection source control.\n   3. Diagnosis of certain deep-seated Candida infections.\n2. Life expectancy of \\\u003C 72 hours in the opinion of the investigator.\n3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.\n4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia \u002F invasive candidiasis are not exclusionary).\n5. Patients with known human immunodeficiency virus infection, who have CD4+ count \\\u003C 200\u002Fmm3 or viral load \\> 400 copies\u002FmL), or who have had an active opportunistic infection within 6 months prior to Screening.\n6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.\n7. Current use of any prohibited concomitant medications or those unwilling\u002Funable to use a permitted concomitant medication.\n8. Received \\> 2 days (\\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and\u002For invasive candidiasis (e.g., \\> 2 doses of a once daily antifungal agent or \\> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).\n9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).\n10. Prior participation in this or any previous study of fosmanogepix.\n11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \\> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.\n12. Female patient is pregnant or lactating.\n13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.\n14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.","ALL","18 Years",{"count":19,"type":20},450,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and\u002For invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.\n\nThe study is seeking patients who have a diagnosis of candidemia and\u002For invasive candidiasis.\n\nTwo-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules.\n\nFosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital.\n\nThe treatment effect in patients receiving fosmanogepix to those receiving caspofungin\u002F fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin\u002F fluconazole with a noninferiority margin of 15%.\n\nThe duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.",[26,27],"Candidemia","Candidiasis, Invasive",[29,30,31,32],"Fungal infection","Candida","Anti-fungal","Yeast","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2024-12-11",{"date":41,"type":20},"2028-01-30",{"name":43,"class":44},"Basilea Pharmaceutica","INDUSTRY",143,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100585870","a-study-comparing-short-course-antifungal-therapy-scat-7-day-vs-standard-14-day-antifungal-therapy-for-uncomplicated-candidemia-100585870","NCT06907992","A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia","Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)","SCAT","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.\n3. Received \\\u003C 5 days of prior antifungal therapy\n4. Informed Consent for randomization\n5. Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.\n\nExclusion Criteria:\n\n1. Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).\n2. Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)\n3. Abnormal LFTs \\> 10-fold\n4. Greater than 5 days of prior antifungal therapy\n5. Endovascular devices that cannot be removed.\n6. Immunocompromised patients (AIDS\u002FHIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of \\\u003C 1,500 cells\u002FL\n7. Neutropenic at time of consent (what does this mean)\n8. Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)\n9. Unable to provide informed consent from either the patient or legally authorized authority (LAR)\n10. Expected mortality within 96 hours",{"count":55,"type":20},150,"OBSERVATIONAL","The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.",[26],[60,61,62,63,64,65,66,67],"candidemia","uncomplicated candidemia","antifungal therapy","echinocandin","caspofungin","micafungin","rezafungin","anidulafungin","NOT_YET_RECRUITING","2025-04-02",{"date":71,"type":37},"2025-04-04",{"date":73,"type":20},"2025-05-01",{"date":75,"type":20},"2027-12-31",{"name":77,"class":78},"Augusta University","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100582158","phase-3-a-randomized-study-of-a-short-duration-therapy-for-candidemia-100582158","NCT06859671","A Randomized Study of a Short Duration Therapy for Candidemia","CANDISHORT","Inclusion Criteria:\n\n* Adults (Age ≥ 18 years old)\n* With an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis.\n* Without expected aplasia duration greater than 7 days\n* Being apyretic and having a 1st negative blood culture after diagnosis\n* Removal of the vascular catheter if present\n* Written informed consent from the patients or his\u002Fher relatives\n* Patients with less than 7 days of aplasia predictable\n\nExclusion Criteria:\n\n* Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment\n* Patients with more than 7 days of aplasia\n* Candida strain resistant to the antifungal used\n* Pregnancy, breastfeeding\n* Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments.\n* unwilling, in the judgment of the investigator, to comply with the protocol\n* Patient under legal guardianship or without healthcare coverage\n* Women with childbearing potential not using adequate contraception",{"count":88,"type":20},362,[23],"Scientific justification Candidemia is a major public health problem. In France, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years.\n\nThe duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the Rex trial (1) comparing the efficacy of fluconazole vs amphotericin B where the minimum duration of treatment was imposed. The risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic.\n\nA retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21\u002F78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. In addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity.\n\nThere is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.",[92],"CANDIDEMIA","2025-02-28",{"date":95,"type":37},"2025-03-05",{"date":97,"type":20},"2025-07-01",{"date":99,"type":20},"2027-09-01",{"name":101,"class":78},"Assistance Publique - Hôpitaux de Paris"]