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Clinical trials for Fidaxomicin

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   44336   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    13 result(s) found for: Fidaxomicin. Displaying page 1 of 1.
    EudraCT Number: 2013-000508-40 Sponsor Protocol Number: 2819-CL-0202 Start Date*: 2014-11-18
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid ...
    Medical condition: Treatment of enterocolitis caused by Clostridium difficile
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10012734 Diarrhea, Clostridium difficile LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) SK (Completed) PL (Completed) IT (Completed) ES (Completed) HU (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003002-32 Sponsor Protocol Number: 2819-MA-1003 Start Date*: 2015-05-05
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)
    Medical condition: Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10022661 Intestinal infection due to clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) AT (Completed) GR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001448-75 Sponsor Protocol Number: OPT-80-206 Start Date*: 2014-09-15
    Sponsor Name:Optimer Pharmaceutical, Inc. (a Cubist company)
    Full Title: A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridiu...
    Medical condition: Clostridium difficile infections (CDI), also known as Clostridium difficile- associated diarrhea
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004619-31 Sponsor Protocol Number: 2819-MA-1002 Start Date*: 2014-09-01
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clo...
    Medical condition: Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10022661 Intestinal infection due to clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) GB (Completed) CZ (Completed) DK (Completed) DE (Completed) IT (Completed) GR (Completed) SI (Completed) HU (Completed) IE (Completed) AT (Completed) BE (Completed) PT (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-005483-25 Sponsor Protocol Number: SMT19969/C003 Start Date*: 2014-10-08
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200 mg BID) for 10 days Compared with Fidaxomicin (200 mg BID) for 10 days f...
    Medical condition: Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-000531-88 Sponsor Protocol Number: FID-EC-0001 Start Date*: 2012-08-30
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile...
    Medical condition: Adult patients with Clostridium difficile infection who are receiving immunosuppressive therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061043 Clostridial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Prematurely Ended) AT (Completed) IT (Prematurely Ended) FI (Prematurely Ended) GB (Completed) DE (Prematurely Ended) HU (Completed) GR (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004591-17 Sponsor Protocol Number: ICD-01 Start Date*: 2021-04-23
    Sponsor Name:Mikrobiomik Healthcare Company S.L.
    Full Title: A randomised, controlled, open-label phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the efficacy and safety of capsules of lyophilised faec...
    Medical condition: Recurrent Clostridioides difficile (CD) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053021 Gram-positive bacterial infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003004-24 Sponsor Protocol Number: 2015-003004-24 Start Date*: 2015-11-13
    Sponsor Name:Aarhus University Hospital
    Full Title: Faecal microbiota transplantation for relapsing Clostridium difficile infection
    Medical condition: Relapsing Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10009657 Clostridium difficile colitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-004994-94 Sponsor Protocol Number: 3415A-002 Start Date*: 2011-12-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to C. difficile toxin B), and MK-...
    Medical condition: Recurrence of Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DE (Completed) CZ (Completed) FI (Completed) PL (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004590-90 Sponsor Protocol Number: 3415A-001 Start Date*: 2012-02-17
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium ...
    Medical condition: recurrence of Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) BE (Completed) DK (Completed) PT (Completed) AT (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-004291-12 Sponsor Protocol Number: 101.1.C.004 Start Date*: 2008-08-18
    Sponsor Name:Optimer Pharmaceuticals, Inc.
    Full Title: A multi-national, multi-centre, double-blind, randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subject...
    Medical condition: Clostridium difficile associated diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) ES (Completed) FR (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000070-11 Sponsor Protocol Number: MK-6072-001 Start Date*: 2017-12-11
    Sponsor Name:Merck Sharp & Dohme Corp.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK 6072, Human Monoclonal An...
    Medical condition: Prevention of recurrent Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) PT (Completed) SE (Prematurely Ended) DE (Completed) NO (Completed) HU (Completed) PL (Completed) Outside EU/EEA GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-004924-14 Sponsor Protocol Number: BSTEP Start Date*: 2022-04-21
    Sponsor Name:Leiden University Medical Center
    Full Title: New treatment strategy for patients with multiple recurrent Clostridioides difficile infection with bezlotoxumab as first option
    Medical condition: recurrent C. difficile infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10009657 Clostridium difficile colitis PT
    20.0 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    20.0 10021881 - Infections and infestations 10012734 Diarrhea, Clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
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    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.

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