Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Micafungin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44343   clinical trials with a EudraCT protocol, of which   7372   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    15 result(s) found for: Micafungin. Displaying page 1 of 1.
    EudraCT Number: 2012-000904-14 Sponsor Protocol Number: MICA_HDF Start Date*: 2012-07-19
    Sponsor Name:Medizinische Universität Wien
    Full Title: PHARMACOKINETICS OF MICAFUNGIN DURING CONTINUOUS VENOVENOUS HEMOFILTRATION
    Medical condition: Suspected or proven candida infection requiring parenteral antifungal therapy
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10042941 Systemic fungal infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003172-39 Sponsor Protocol Number: Mica1/2012 Start Date*: 2013-05-23
    Sponsor Name:Medizinische Universität Innsbruck, Abteilung für Hygiene und Medizinische Mikrobiologie
    Full Title: Micafungin-Deescaltion study: Evalutating the rate of breakthrough infections of micafungin followed by fluconazole versus fluconazole (or other azoles) in febrile patients
    Medical condition: All patients who are suspicious of suffering from invasive fungal infections are included.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001916-41 Sponsor Protocol Number: C11-11 Start Date*: 2014-11-24
    Sponsor Name:Inserm
    Full Title: Fluconazole versus Micafungin in neonates with suspected or culture-proven Candidiasis: a randomized pharmacokinetic and safety study
    Medical condition: Neonates with suspected or culture-proven candidiasis
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) IT (Prematurely Ended) NL (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002848-93 Sponsor Protocol Number: UMCN-AKF13.02 Start Date*: 2014-01-23
    Sponsor Name:Radboud University Medical Centre
    Full Title: Pharmacokinetics of micafungin (Mycamin ®) as antifungal prophylaxis given twice weekly intravenously compared to micafungin given daily to patients at risk for developing an invasive fungal disease.
    Medical condition: prophylaxis for patients at high risk for invasive fungal diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10017533 Fungal infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003087-20 Sponsor Protocol Number: 800_OPBG_2014 Start Date*: 2014-11-12
    Sponsor Name:IRCCS Ospedale Pediatrico Bambino Gesù
    Full Title: Determination of Plasmatic and CSF Levels Of High Doses Of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida meningitis.
    Medical condition: Systemic Candidiasis and/or Candida Meningitis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10027238 Meningitis fungal NOS LLT
    17.0 100000004852 10027237 Meningeal fungal infections HLT
    17.0 100000004862 10042941 Systemic fungal infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004988-27 Sponsor Protocol Number: FG-463-21-20 Start Date*: 2006-07-27
    Sponsor Name:Astellas Pharma BV
    Full Title: A PHASE II, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MICAFUNGIN SALVAGE MONO THERAPY VERSUS ACTIVE CONTROL INTRAVENOUS SALVAGE MONO THE...
    Medical condition: Patients with haematopoietic stem cell transplantation (HSCT), acute leukaemia, myelodysplastic syndrome (MDS) and with proven (probable only in case of pulmonary aspergillosis) invasive aspergillo...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10022881 Invasive bronchopulmonary aspergillosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) ES (Completed) HU (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005214-49 Sponsor Protocol Number: 9463-EC-0001 Start Date*: 2009-10-30
    Sponsor Name:Astellas Pharma Europe Ltd
    Full Title: Randomized, Open label, Non-inferiority Study of Micafungin versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
    Medical condition: Fungal infection.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042941 Systemic fungal infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IE (Completed) HU (Completed) ES (Completed) FR (Completed) DE (Completed) PT (Completed) CZ (Completed) IT (Completed) SE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000780-24 Sponsor Protocol Number: 9463-CL-2303 Start Date*: 2012-07-24
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
    Medical condition: Neonatal Candidiasis
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-000103-16 Sponsor Protocol Number: RC13_0008 Start Date*: 2013-06-21
    Sponsor Name:CHU de Nantes
    Full Title: Antifungal prophylaxis with Micafungin after cord blood allogeneic stem cell transplantation.
    Medical condition: Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10010980 Cord blood transplant therapy PT
    18.0 10042613 - Surgical and medical procedures 10049085 Antifungal prophylaxis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005065-38 Sponsor Protocol Number: ECHI-TS-2 Start Date*: 2014-02-17
    Sponsor Name:Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I
    Full Title: Concentrations of echinocandins in ascites, pleural effusion, bile, wound secretion and cerebrospinal fluid – a pilot study
    Medical condition: Invasive fungal infection treated with an echinocandin and indication for paracentesis, thoracentesis, bile deviation or sampling, lumbar puncture or VAC therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001491-39 Sponsor Protocol Number: 03-0-192 Start Date*: 2005-02-16
    Sponsor Name:Astellas Pharma US, Inc.
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIA
    Medical condition: Invasive candidiasis or candidemia
    Disease: Version SOC Term Classification Code Term Level
    7.0 10042938 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) BE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005451-14 Sponsor Protocol Number: 1126 Start Date*: 2011-12-07
    Sponsor Name:University Hospital, Grenoble
    Full Title: Micafungine versus placebo au cours du sepsis nosocomial chez des patients multi-colonisés à candida : Essai randomisé contrôlé EMPIRICUS
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006409-18 Sponsor Protocol Number: 9463-EC-0002 Start Date*: 2010-02-09
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, D...
    Medical condition: Invasive Candidiasis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10007152 Candidiasis LLT
    12.1 10007162 Candidiasis of the intestine LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) HU (Completed) BE (Completed) GR (Completed) DE (Completed) FR (Completed) FI (Completed) IT (Completed) GB (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004008-37 Sponsor Protocol Number: Gandalf-01 Start Date*: 2013-07-05
    Sponsor Name:GITMO
    Full Title: A phase II multicentre open-label study on allogeneic stem cell transplantation from unrelated, cord-blood and family haploidentical donors in patients with active acute leukemia
    Medical condition: Any active acute leukemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10000835 Acute leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000648-32 Sponsor Protocol Number: SCY-078-302 Start Date*: 2023-03-31
    Sponsor Name:SCYNEXIS, Inc.
    Full Title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp ver...
    Medical condition: Invasive Candidiasis/ Candidemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10060573 Candidemia LLT
    20.0 10021881 - Infections and infestations 10064954 Invasive candidiasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) FR (Trial now transitioned) ES (Temporarily Halted) BE (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Jun 16 08:51:32 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA