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Clinical trials for Burkholderia cepacia

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   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).

    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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    9 result(s) found for: Burkholderia cepacia. Displaying page 1 of 1.
    EudraCT Number: 2009-011740-19 Sponsor Protocol Number: GS-US-205-0127 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) a...
    Medical condition: Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-000219-25 Sponsor Protocol Number: MRSA Start Date*: 2013-07-18
    Sponsor Name:AOU Meyer
    Full Title: Early eradication of S. Aureus (MRSA) in patients with cystic fibrosis: a randomized multicenter study.
    Medical condition: Patients affected by cystic fibrosis and who present an initial infection of MRSA.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-006276-11 Sponsor Protocol Number: VR496/005 Start Date*: 2008-09-01
    Sponsor Name:Vectura Limited
    Full Title: A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cys...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011763 Cystic fibrosis lung LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012575-10 Sponsor Protocol Number: CH/2007/2661 Start Date*: 2009-11-16
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust [...]
    1. University Hospitals Bristol NHS Foundation Trust
    2. University of Liverpool
    Full Title: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis
    Medical condition:
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004208-39 Sponsor Protocol Number: BAYq3939/15625 Start Date*: 2013-01-21
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus p...
    Medical condition: bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) IT (Completed) DK (Completed) FR (Completed) LV (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2010-018738-27 Sponsor Protocol Number: CF2110399 Start Date*: 2010-06-02
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011763 Cystic fibrosis lung LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004659-19 Sponsor Protocol Number: BAYQ3939/15626 Start Date*: 2014-04-23
    Sponsor Name:Bayer AG
    Full Title: Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus p...
    Medical condition: non-CF bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) LT (Completed) AT (Completed) CZ (Completed) PT (Completed) BG (Completed) LV (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2016-001785-29 Sponsor Protocol Number: ARIS2 Start Date*: 2016-08-15
    Sponsor Name:St. Vincent's University Hospital
    Full Title: Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment
    Medical condition: Cystic fibrosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002677-38 Sponsor Protocol Number: CTX-4430-CF-201 Start Date*: 2016-02-04
    Sponsor Name:Celtaxsys Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) BE (Completed)
    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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