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Clinical trials for Safety culture

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    699 result(s) found for: Safety culture. Displaying page 1 of 35.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2008-005278-11 Sponsor Protocol Number: A8851022 Start Date*: 2009-03-06
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN PATIENTS WITH CANDIDA DEEP TISSUE INFECTION
    Medical condition: INVASIVE CANDIDIA INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064954 Invasive candidiasis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) BE (Prematurely Ended) IE (Prematurely Ended) NL (Prematurely Ended) BG (Prematurely Ended)
    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: 2011-003087-70 Sponsor Protocol Number: PM1125 Start Date*: 2011-12-02
    Sponsor Name:Polichem SA
    Full Title: Randomized, open-label, controlled study on the efficacy of Ciclopoli® (ciclopirox 8% nail lacquer) versus Loceryl® (amorolfine 5% nail lacquer) on the culture conversion to negative in patients w...
    Medical condition: distal subungual onychomycosis without lunula involvement due to fungal nail pathogens (dermatophytes, white yeasts and/or Scopulariopsis spp. and/or Fusarium spp.) affecting at least one big toenail
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (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: 2008-005277-35 Sponsor Protocol Number: A8851021 Start Date*: 2009-02-26
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN NEUTROPENIC PATIENTSWITH INVASIVE CANDIDA INFECTION
    Medical condition: INVASIVE CANDIDIA INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064954 Invasive candidiasis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) IE (Prematurely Ended) SK (Prematurely Ended) FR (Completed) IT (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003722-24 Sponsor Protocol Number: MOB015B-II Start Date*: 2012-10-17
    Sponsor Name:Moberg Derma AB
    Full Title: An open, single-centre pilot study of efficacy and safety of topical MOB015B in the treatment of distal subungual onychomycosis (DSO)
    Medical condition: Distal subungual onychomycosis (DSO)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004440-19 Sponsor Protocol Number: CLAM320B2202 Start Date*: 2016-03-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 30-month multicenter, phase 2b/3, randomized, open label trial to evaluate the efficacy and safety of clofazimine administered orally in addition to background regimen compared to background regi...
    Medical condition: Treatment of multidrug-resistant pulmonary tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10070578 Multidrug resistant tuberculosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002955-33 Sponsor Protocol Number: 027SC10363 Start Date*: 2012-02-16
    Sponsor Name:Aziende Chimiche Riunite Angelini Francesco S.p.A
    Full Title: Clinical and microbiological assessment of prulifloxacin in patients with Acute Bacterial Rhinosinusitis (ABRS)
    Medical condition: Male or female adults with ABRS, defined as the presence of 2 (including at least one between nasal blockage/congestion/ obstruction or nasal discharge) or more of the following signs and symptoms:...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-001699-43 Sponsor Protocol Number: BPR-CS-009 Start Date*: 2018-12-13
    Sponsor Name:Basilea Pharmaceutica International Ltd
    Full Title: A randomized, double-blind, multi-center study to establish the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including ...
    Medical condition: Complicated staphylococcus aureus bacteremia (cSAB)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10058887 Staphylococcus aureus bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) BG (Completed) ES (Completed) IT (Completed) GR (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003079-16 Sponsor Protocol Number: INS-416 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen ...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10021881 - Infections and infestations 10061229 Lung infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) FR (Trial now transitioned) DE (Ongoing) AT (Trial now transitioned) HU (Completed) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004854-97 Sponsor Protocol Number: A8851019 Start Date*: 2008-01-15
    Sponsor Name:Pfizer Ltd
    Full Title: OPEN-LABEL, NON-COMPARATIVE, STUDY OF INTRAVENOUS ANIDULAFUNGIN, FOLLOWED OPTIONALLY BY ORAL VORICONAZOLE OR FLUCONAZOLE THERAPY, FOR TREATMENT OF DOCUMENTED CANDIDEMIA/INVASIVE CANDIDIASIS IN INTE...
    Medical condition: CANDIDAEMIA/INVASIVE CANDIDIASIS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064954 Invasive candidiasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) FR (Completed) BE (Completed) PT (Completed) NL (Completed) IT (Completed) SK (Completed) PL (Completed) CZ (Completed) DK (Completed) HU (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-001626-22 Sponsor Protocol Number: RML-TB Start Date*: 2022-03-28
    Sponsor Name:Vall d'Hebron Institute of Research
    Full Title: A Multicentre Controlled Open Randomized Clinical Trial to evaluate the efficacy and safety profile of an anti-TB drug combination based on High Dose Rifampicin, High Dose Moxifloxacin and Linezoli...
    Medical condition: Smear-positive rifampicin-sensitive pulmonary Tuberculosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005929-49 Sponsor Protocol Number: VX11-787-101 Start Date*: 2012-02-20
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2a, Randomized, Double Blind, Placebo Controlled Study to Investigate the Effects of VX 787 Administered to Adult Volunteers Experimentally Inoculated with Live Influenza Virus
    Medical condition: Influenza A
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022002 Influenza A virus infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000789-35 Sponsor Protocol Number: HPTM06/J/05 Start Date*: 2006-10-06
    Sponsor Name:INFAI GmbH
    Full Title: Two-way Crossover Comparison of the Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal vs. Standard 13C-Urea Breath Test in Helicobacter Pylori Positive and Neg...
    Medical condition: Diagnosis of Helicobacter pylori infection for patients taking proton pump inhibitors (PPI) without interuption of medication two weeks prior to test.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003604-12 Sponsor Protocol Number: ITM201902 Start Date*: 2020-01-15
    Sponsor Name:Institute of Tropical Medicine
    Full Title: Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection
    Medical condition: asymptomatic pharyngeal Neisseria gonorrhoeae (NG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10051970 Neisseria gonorrhoeae infection LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004804-38 Sponsor Protocol Number: 073-202 Start Date*: 2011-12-13
    Sponsor Name:ViroDefense Inc
    Full Title: A Randomized, Blinded, Placebo-Controlled, Poliovirus Challenge Study To Evaluate The Therapeutic Efficacy, Safety, Tolerability And Pharmacokinetics Of Orally Administered V-073 In Healthy Adult V...
    Medical condition: Poliomyelitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10036017 Poliomyelitis viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001269-18 Sponsor Protocol Number: VMT-VT-1161-CL-011 Start Date*: 2019-03-13
    Sponsor Name:Mycovia Pharmaceuticals, Inc
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects with Recurrent Vulvovaginal Candidiasis
    Medical condition: Recurrent Vulvovaginal Candidiasis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10047784 Vulvovaginal candidiasis PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BG (Completed) PL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-000653-23 Sponsor Protocol Number: TMC207-TiDP13-C210 Start Date*: 2012-06-13
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Myc...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Prematurely Ended) LV (Completed)
    Trial results: View results
    EudraCT Number: 2006-002839-24 Sponsor Protocol Number: 108134 Start Date*: 2006-08-18
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A randomized, double-blind, placebo-controlled, multi-country and multi-center, phase IV study to demonstrate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscula...
    Medical condition: Immunization against influenza in male and female subjects aged 18 to 64 years
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2018-000244-26 Sponsor Protocol Number: PC-ASP-004 Start Date*: 2018-08-21
    Sponsor Name:Pulmocide Ltd
    Full Title: A double-blind, placebo-controlled study to assess the effects of inhaled PC945 in the treatment of culture-positive Aspergillus or Candida fungal bronchitis in subjects with moderate to severe ast...
    Medical condition: Pulmonary aspergillosis and candidiasis of lung
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10059259 Pulmonary aspergillosis LLT
    20.0 100000004862 10007155 Candidiasis of lung LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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