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Clinical trials for Mycobacterium avium complex

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    6 result(s) found for: Mycobacterium avium complex. Displaying page 1 of 1.
    EudraCT Number: 2014-005010-31 Sponsor Protocol Number: INS-212 Start Date*: 2015-07-03
    Sponsor Name:Insmed Inc.
    Full Title: A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium avium comple...
    Medical condition: Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10058806 Mycobacterium avium complex infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed) NL (Completed) ES (Completed) PL (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003170-33 Sponsor Protocol Number: INS-312 Start Date*: 2016-03-14
    Sponsor Name:Insmed Inc.
    Full Title: An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacter...
    Medical condition: Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10058806 Mycobacterium avium complex infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) ES (Completed) PL (Completed) NL (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000938-20 Sponsor Protocol Number: 2019-5172 Start Date*: 2021-04-15
    Sponsor Name:Radboudumc
    Full Title: Pharmacokinetic study of minocycline in patients with pulmonary nontuberculous mycobacterial disease
    Medical condition: Pulmonary disease caused by Mycobacterium avium complex. Mycobacterium avium complex is a nontuberculous mycobacterium.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001087-38 Sponsor Protocol Number: PI2017_843_0010 Start Date*: 2017-09-15
    Sponsor Name:CHU Amiens-Picardie
    Full Title: CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections: A randomized prospective controlled study
    Medical condition: Mycobacterium avium complex pulmonary infections
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002545-42 Sponsor Protocol Number: INS-415 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous M...
    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
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) HU (Completed) AT (Completed) NL (Completed) GR (Completed) IT (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)
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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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