[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-fungal-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-fungal-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,114,141],{"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":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641346","liposomal-amphotericin-b-for-invasive-fungal-disease-in-solid-organ-transplant-recipients-100641346",false,"NCT07656493","Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients","A Real-World Observational Study of the Effectiveness, Safety, and Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease","LAMB-SOT","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Recipient of a solid organ transplant.\n* Diagnosis of invasive fungal disease (IFD) according to EORTC\u002FMSGERC criteria.\n* Receiving liposomal amphotericin B therapy as part of routine clinical care.\n* Provision of informed consent for prospective participants.\n\nExclusion Criteria:\n\n* Known hypersensitivity to amphotericin B formulations.\n* Severe hepatic dysfunction (ALT or AST \\>5× upper limit of normal, or total bilirubin \\>2× upper limit of normal).\n* Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.\n* Pregnancy or breastfeeding.\n* Participation judged inappropriate by the investigator.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.\n\nThis is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.\n\nThe study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.\n\nThe primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.\n\nThe study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.",[25,26,27],"Invasive Fungal Infection","Solid Organ Transplantation","Opportunistic Infections",[29,26,30,31,32,33,34,35,36,37],"Liposomal Amphotericin B","Invasive Fungal Disease","Antifungal Therapy","Tacrolimus","Cyclosporine","Therapeutic Drug Monitoring","Drug-Drug Interaction","Real-World Study","Transplant Infection","NOT_YET_RECRUITING","2026-06-19",{"date":41,"type":42},"2026-06-24","ACTUAL",{"date":44,"type":21},"2026-07-01",{"date":46,"type":21},"2028-06-30",{"name":48,"class":49},"Sichuan Provincial People's Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":59,"type":21},100,"INTERVENTIONAL",[62],"PHASE4","This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,25,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pyoderma Gangrenosum","Pterygium","Hypospadias","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Pouchitis","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Epidermolysis Bullosa (EB)","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","2026-05-01",{"date":107,"type":42},"2026-05-05",{"date":109,"type":21},"2026-08",{"date":111,"type":21},"2035-12",{"name":113,"class":49},"Jay C. Buckey Jr.",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":60,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100413549","phase-2-posaconazole-mk-5592-intravenous-and-oral-in-children-2-years-with-invasive-fungal-infection-mk-5592-127-100413549","NCT04665037","Posaconazole (MK-5592) Intravenous and Oral in Children (\u003C2 Years) With Invasive Fungal Infection (MK-5592-127)","A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection","Inclusion Criteria:\n\n* Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)\n* Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)\n* Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention.\n* Has a body weight of ≥500 g\n* The participant (or legally acceptable representative) has provided documented informed consent for the study.\n\nExclusion Criteria\n\n* Has received POS within 30 days before Day 1\n* Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis\n* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Has known or suspected active COVID-19 infection\n* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used\n* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention\n* Has received any listed prohibited medications within the specified timeframes before the start of study intervention\n* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)\n* Has suspected\u002Fproven invasive candidiasis (Part B)\n* Has enrolled previously in the current study and been discontinued\n* Has QTc prolongation at screening \\>500 msec\n* Has significant liver dysfunction\n* Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days","1 Day","2 Years",{"count":124,"type":21},40,[126],"PHASE2","This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \\\u003C2 years of age with invasive fungal infection (IFI).",[25],"RECRUITING","2025-09-17",{"date":132,"type":42},"2025-09-18",{"date":134,"type":42},"2022-02-22",{"date":136,"type":21},"2026-12-31",{"name":138,"class":139},"Merck Sharp & Dohme LLC","INDUSTRY",26,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":60,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":50},"100568199","phase-1-study-to-assess-the-safety-and-efficacy-of-intravenous-bsg005-in-patients-with-invasive-fungal-infection-100568199","NCT06678113","Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection","A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection","Inclusion Criteria:\n\n1. Age 18 years.\n2. Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.\n3. Diagnosed by Investigator to have an IFI.\n\n   \\- Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and Treatment of Cancer\u002F Mycoses Study Group Education and Research Consortium (EORTC\u002FMSGERC). Probable or possible IFIs can be included using the EORTC\u002FMSGERC criteria or other established criteria. The inclusion of patients with IFI caused by, eg, Aspergillus spp and Candida spp, is preferred as these species are generally known to be responsive to a lower dose than other species, eg, Mucor mycosis\n4. IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due to any of the following\n\n   1. Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or beta-D-glucan, Failure of clearance of cultures , Progression or lack of improvement in a clinically appropriate timeframe of clinical symptoms attributed to IFI;\n   2. Inability to tolerate AmB, as defined by at least one of the following: Nephrotoxicity with either: 1.5 mg\u002FdL increase in creatinine from baseline, 50% increase in creatinine from baseline ii. Contraindication to use AmB with either:- Persistent hypokalemia or hypomagnesemia while on AmB despite appropriate electrolyte replacement\n   3. Documented in vitro resistance to first-line antifungal therapy (ie fluconazole resistance in Candida auris)\n   4. Treatment-limiting drug-drug interactions prohibiting the use of antifungals (azoles and echinocandins) such as concurrent rifampcin, rifabutin, phenytoin, carbamazepine, bedaqualine\n\nExclusion Criteria:\n\n1. Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.\n2. Infection caused by a known or suspected organism with intrinsic resistance to AmB.\n3. Concurrent use of another investigational agent within 30 days of enrollment.\n4. Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin or dialysis. Patients with acute kidney injury with eGFR less than 30 mL\u002Fmin and improving creatinine level can be included as judged by the Investigator.\n\n   Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.\n5. Has liver enzyme results (aspartate aminotransferase \\[AST\\]\u002Falanine aminotransferase \\[ALT\\]) greater than 5 times the upper limit of normal.\n\n   Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.\n6. Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.\n7. Patients who have an ejection fraction less than 25% of predicted.\n8. Currently pregnant or planning on getting pregnant while on study (details of contraception guidance are provided in Section 13).\n9. Breastfeeding.\n10. Patients not likely to survive a minimum of 28 days from start of screening.\n11. Patient receiving prohibited medications.\n12. Patient is an abuser of alcohol or medication.\n\n    \\-","100 Years",{"count":150,"type":21},15,[152,126],"PHASE1","This study is an open-label, Phase 1b, dose-escalation\u002Ffinding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI).\n\nApproximately 15 patients are planned to be enrolled in 3 cohorts. The study will be conducted in 3 cohorts consisting of 3 periods, namely: Screening, Treatment, and Follow-up periods. In each cohort, 5 patients are planned to be enrolled.\n\nThis study is a single-arm study. The treatment (BSG005) in each dose level will be administered once daily for 3 days via IV infusion. If the safety and tolerability profiles are acceptable at each dose level, the patients will be treated for a maximum of 28 days. Each patient will be in the study for up to 50 days, which consists of a 7-day Screening period, 1 day for baseline assessments, up to 28 days (maximum) of treatment with BSG005, and 14 days of follow-up.",[25],[156,157,158,159],"Invasive fungal infection","BSG005","Polyene macrolide","Rescue therapy","2025-04-03",{"date":162,"type":42},"2025-04-06",{"date":164,"type":42},"2024-07-01",{"date":166,"type":21},"2026-04-01",{"name":168,"class":139},"Biosergen AS"]