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Clinical trials for Clostridia

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   44339   clinical trials with a EudraCT protocol, of which   7369   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.
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    16 result(s) found for: Clostridia. Displaying page 1 of 1.
    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: 2010-020941-29 Sponsor Protocol Number: AC-061A201 Start Date*: 2010-11-03
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, double-blind, randomized, active reference, parallel group study to evaluate the efficacy, safety and tolerability of a 10-day twice daily oral administration of 3 doses of ACT-1798...
    Medical condition: Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054236 Clostridium difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) IT (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: 2013-002528-17 Sponsor Protocol Number: AC-061A301 Start Date*: 2014-03-14
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002508-15 Sponsor Protocol Number: AC-061A302 Start Date*: 2014-03-03
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) SK (Completed) GR (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: 2014-003934-22 Sponsor Protocol Number: VLA84-201 Start Date*: 2014-12-10
    Sponsor Name:Valneva Austria GmbH
    Full Title: DOSE-CONFIRMATION, IMMUNOGENICITY AND SAFETY STUDY OF THE CLOSTRIDIUM DIFFICILE VACCINE CANDIDATE VLA84 IN HEALTHY ADULTS AGED 50 YEARS AND OLDER. RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE II S...
    Medical condition: Prevention against Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000947-26 Sponsor Protocol Number: CLFF571X2201 Start Date*: 2012-08-28
    Sponsor Name:Novartis Farmacéutica S.A
    Full Title: Multi-center, randomized, evaluator-blind, active-controlled, parallel-group design to determine safety, tolerability, and efficacy of multiple daily administration of LFF571 for 10 days in patien...
    Medical condition: Clostridium difficile infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PT (Prematurely Ended)
    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)
    EudraCT Number: 2015-004805-17 Sponsor Protocol Number: AC-061A303 Start Date*: 2017-07-12
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10012734 Diarrhea, Clostridium difficile LLT
    19.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    19.1 10021881 - Infections and infestations 10022661 Intestinal infection due to clostridium difficile LLT
    19.1 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-020484-20 Sponsor Protocol Number: 20621-200 Start Date*: 2011-07-05
    Sponsor Name:ViroPharma Incorporated
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO ASSESS THE SAFETY AND EFFICACY OF VP 20621 FOR PREVENTION OF RECURRENCE OF CLOSTRIDIUM DIFFICILE INFECTION (CDI) IN AD...
    Medical condition: Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10054236 Clostridium difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-001641-27 Sponsor Protocol Number: SMT19969/C004 Start Date*: 2019-07-05
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment ...
    Medical condition: Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GR (Prematurely Ended) BG (Completed) ES (Ongoing) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001642-10 Sponsor Protocol Number: SMT19969/C005 Start Date*: 2019-03-13
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment ...
    Medical condition: Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) LT (Completed) BE (Prematurely Ended) DE (Completed) CZ (Completed) ES (Ongoing) FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2008-004907-69 Sponsor Protocol Number: H-030-011 Start Date*: 2008-11-25
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: A Phase II randomized, placebo-controlled, double-blind, dose ranging study of a Clostridium difficile toxoid vaccine (ACAM-CDIFF) in subjects with Clostridium difficile-associated infection(CDI)
    Medical condition: Recurrence of Clostridium difficile Infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10006834 C.difficile diarrhea LLT
    12.0 10006835 C.difficile diarrhoea LLT
    12.0 10012734 Diarrhea, Clostridium difficile LLT
    12.0 10012748 Diarrhoea, Clostridium difficile LLT
    12.0 10022661 Intestinal infection due to clostridium difficile LLT
    12.0 10054236 Clostridium difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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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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