Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Mycobacterium

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   44334   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    85 result(s) found for: Mycobacterium. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    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: 2010-023491-25 Sponsor Protocol Number: MFX468 Start Date*: 2011-01-18
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis
    Medical condition: Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10044755 Tuberculosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006613-10 Sponsor Protocol Number: TMC207LEP3001 Start Date*: 2024-08-13
    Sponsor Name:Janssen Pharmaceutica NV
    Full Title: A Phase 3, Multicenter, Open-label, Rater-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline for the Treatment of Multibacillary Leprosy When Combined With Rifampicin...
    Medical condition: Multibacillary Leprosy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10024232 Leprosy, unspecified LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2008-006765-82 Sponsor Protocol Number: MOXEP Start Date*: 2009-05-29
    Sponsor Name:ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    Full Title: Preventive therapy for multidrug-resistant tuberculosis: a multicentre clincal trial.
    Medical condition: Close contacts of an infectious respiratory of a MDR-TB who are diagnosed with tuberculosis infection that is likely to have been acquired from the MDR-TB case will be eligible for inclusion in th...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028440 HLGT
    9.1 10044756 HLT
    9.1 10021868 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-017430-49 Sponsor Protocol Number: QFT-ECC-01 Start Date*: 2010-04-16
    Sponsor Name:Dr Miguel Santín Cerezales
    Full Title: Ensayo clínico de dos estrategias para la toma de decisiones terapéuticas en el estudo de contactos de tuberculosis: estrategia estándar, basada en la prueba de la tuberculina (PT) sola frente a la...
    Medical condition: Infección Tuberculosa latente
    Disease: Version SOC Term Classification Code Term Level
    9 10021870 Infection tuberculosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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: 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: 2008-008444-25 Sponsor Protocol Number: TMC207-TiDP13-C209 Start Date*: 2009-06-04
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: A Phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB.
    Medical condition: Sputum smear-positive pulmonary 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: LV (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022302-41 Sponsor Protocol Number: FLISH-ILT Start Date*: 2011-03-03
    Sponsor Name:Consorcio de Apoyo a la Investigación Biomédica en Red (CAIBER)
    Full Title: Ensayo clínico prospectivo, aleatorizado, comparativo de la eficacia y seguridad del levofloxacino versus isoniazida en el tratamiento de la infección latente tuberculosa del trasplante hepático
    Medical condition: Pacientes en lista de espera de trasplante hepático
    Disease: Version SOC Term Classification Code Term Level
    13 10010186 Complicaciones del trasplante de hígado LLT
    13 10028458 Infección por Mycobacterium tuberculosis reactivada LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-004462-40 Sponsor Protocol Number: TMC207-TiDP13-C208 Start Date*: 2007-12-20
    Sponsor Name:Tibotec BVBA
    Full Title: A Phase II, placebo-controlled, double-blind, randomized trial to evaluate the anti-bacterial activity, safety, and tolerability of TMC207 in subjects with sputum smear-positive pulmonary infection...
    Medical condition: Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044755 Tuberculosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: LV (Completed)
    Trial results: View results
    EudraCT Number: 2009-017296-17 Sponsor Protocol Number: TESEC-03 Start Date*: 2011-04-04
    Sponsor Name:Statens Serum Institut
    Full Title: A phase IIa specificity trial of the diagnostic agent C-Tb, when given intradermally by the Mantoux technique to healthy volunteers previously vaccinated with BCG
    Medical condition: The intended indication for the product is to be a diagnostic tool to detect infection with M.tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    10 10044755 tuberculosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002202-30 Sponsor Protocol Number: R207910BAC2001 Start Date*: 2004-10-18
    Sponsor Name:Tibotec Pharmaceuticals Ltd.
    Full Title: An open label study to evaluate the effects on Mycobacterium tuberculosis, safety, tolerability and pharmacokinetics of single doses of R207910, in treatment naive patients with mycobacterium tuber...
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003372-23 Sponsor Protocol Number: TMC207-C211 Start Date*: 2015-05-28
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antimycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-021125-12 Sponsor Protocol Number: TMC207TBC3001 Start Date*: 2011-09-16
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: Early access of TMC207 in combination with other anti-tuberculosis (TB) drugs in subjects with extensively drug resistant (XDR) or pre-XDR pulmonary TB
    Medical condition: Tuberculosis (TB)
    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: LT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000513-39 Sponsor Protocol Number: LIN-interaction-01 Start Date*: 2011-07-27
    Sponsor Name:University Medical Center Groningen
    Full Title: The pharmacokinetic effect of clarithromycin on the AUC0-12h of linezolid in multidrug-resistant and extensively drug-resistant tuberculosis patients
    Medical condition: Multidrug-resistant and extensively drug-resistant tubeculosis (MDR/XDR-TB)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10043148 TB LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005492-13 Sponsor Protocol Number: TMC207TBC1002 Start Date*: 2013-03-26
    Sponsor Name:Janssen infectious diseases BVBA
    Full Title: A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatri...
    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 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-005617-36 Sponsor Protocol Number: TESEC-06 Start Date*: 2012-05-30
    Sponsor Name:Statens Serum Institut
    Full Title: A phase III contact tracing trial comparing the diagnostic performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in combination with a double blind randomized split body safety assessment of C-Tb ve...
    Medical condition: Tuberculosis diagnostic tool
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    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: 2021-003301-22 Sponsor Protocol Number: AC-R6 Start Date*: 2021-10-05
    Sponsor Name:Archivel Farma S.L.
    Full Title: A phase IIB study to explore the efficacy and safety of the concomitant administration of RUTI® immunotherapy with the standard treatment in patients with TB (CONSTAN)
    Medical condition: Pulmonary Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 06 18:02:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA