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Clinical trials for Clostridium difficile toxin B

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    The EU Clinical Trials Register currently displays   44335   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).

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    21 result(s) found for: Clostridium difficile toxin B. Displaying page 1 of 2.
    1  2  Next»
    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
    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: 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: 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: 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: 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: 2011-004994-94 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: 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: 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: 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: 2012-000252-34 Sponsor Protocol Number: LCD-CDAD-10-07 Start Date*: 2012-12-06
    Sponsor Name:Cubist Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea
    Medical condition: Clostridium difficile Associated Diarrhea
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004862 10012734 Diarrhea, Clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) DE (Completed) CZ (Completed) PL (Completed) ES (Completed) AT (Completed) GB (Completed) IT (Completed) HU (Completed)
    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: 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: 2015-003062-82 Sponsor Protocol Number: RBI/FMT-CDI Start Date*: 2016-11-01
    Sponsor Name:Department of Medicine, Zealand University Hospital
    Full Title: Rectal Bacteriotherapy, Faecal microbiota transplantation or oral vancomycin for the treatment of recurrent Clostridium Difficile infection: A randomised controlled trial
    Medical condition: Recurrent infection with Clostridium Difficile
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10072994 Clostridium difficile infection recurrence LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000775-32 Sponsor Protocol Number: H-030-014 Start Date*: 2013-08-13
    Sponsor Name:Sanofi Pasteur Inc
    Full Title: Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection
    Medical condition: Prevention of primary Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    20.0 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    20.0 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    20.0 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) GB (Completed) DE (Completed) ES (Completed) DK (Completed) PL (Completed) CZ (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-004531-36 Sponsor Protocol Number: MU1646 Start Date*: 2018-09-03
    Sponsor Name:Ardeypharm GmbH
    Full Title: Escherichia coli strain Nissle 1917 - Suspension for treatment of patients with Clostridium difficile associated diarrhoea
    Medical condition: Clostridium difficile associated diarrhoea (CDAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-002636-31 Sponsor Protocol Number: APHP211034 Start Date*: 2022-09-15
    Sponsor Name:Assistance Publique Hôpitaux de Paris/DRCI
    Full Title: Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the in...
    Medical condition: severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-006269-17 Sponsor Protocol Number: SPON1069-11 Start Date*: 2012-11-16
    Sponsor Name:Cardiff University, Research & Development Commercial Department
    Full Title: A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in Sout...
    Medical condition: Antibiotic Associated Diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001956-22 Sponsor Protocol Number: CNTO1275CRD1001 Start Date*: 2017-01-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease
    Medical condition: Moderately to severely active Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) PL (Completed) FR (Completed) Outside EU/EEA
    Trial results: View results
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