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Clinical trials for Mycobacteria

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    12 result(s) found for: Mycobacteria. Displaying page 1 of 1.
    EudraCT Number: 2009-015744-42 Sponsor Protocol Number: NA Start Date*: 2009-12-03
    Sponsor Name:Oxford Radcliffe Hospitals Trust
    Full Title: Randomized open label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: Preliminary study in a single centre.
    Medical condition: Bone and joint infection including; o Osteomyelitis. o Septic arthritis. o Prosthetic joint associated infection o Orthopaedic device associated infection o Discitis/ epidural abscess
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001167-93 Sponsor Protocol Number: Sobi.IMMUNO-101 Start Date*: 2020-03-27
    Sponsor Name:SWEDISH ORPHAN BIOVITRUM AB (PUBL)
    Full Title: A phase 2/3, randomized, open-label, parallel group, 3-arm, multicenter study investigating the efficacy and safety of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN¿...
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002062-40 Sponsor Protocol Number: UMCN-AKF-21.04 Start Date*: 2021-11-29
    Sponsor Name:Radboud university medical center
    Full Title: Pharmacokinetic study with a loading dose of clofazimine in adult patients with nontuberculous mycobacterial disease
    Medical condition: Nontuberculous mycobacterial disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000801-39 Sponsor Protocol Number: PsAer-IgY Start Date*: 2011-08-31
    Sponsor Name:Mukoviszidose Institute gGmbH
    Full Title: Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention ...
    Medical condition: Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnorma...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10011764 Cystic fibrosis NOS LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) BE (Completed) IT (Completed) IE (Completed) HU (Completed) AT (Completed) ES (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: 2016-004033-25 Sponsor Protocol Number: PED-FQ-2016 Start Date*: 2017-06-19
    Sponsor Name:Fundació Parc Taulí
    Full Title: Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10074550 Preventive antimicrobial therapy in cystic fibrosis LLT
    20.0 100000004850 10011764 Cystic fibrosis NOS LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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: 2009-014944-13 Sponsor Protocol Number: 242-08-210 Start Date*: 2009-11-06
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Pati...
    Medical condition: Pulmonary Multidrug-resistant Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10037440 Pulmonary tuberculosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000679-16 Sponsor Protocol Number: EORTC 06023 Start Date*: 2005-05-17
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Randomized phase II trial with infliximab (Remicade) in patients with myelodysplastic syndrome and a relatively low risk of developing acute leukemia
    Medical condition: myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    7.1 10028533 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-002192-23 Sponsor Protocol Number: GS-US-404-1808 Start Date*: 2016-06-03
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004084-10 Sponsor Protocol Number: T001018N Start Date*: 2022-05-16
    Sponsor Name:Flemisch Fund for Scientific Research - Fonds voor Wetenschappelijk Onderzoek
    Full Title: Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment; a pragmatic randomised controlled trial
    Medical condition: Rifampicin resistant (RR-TB) and drug resistant (DR-TB) tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10049031 Genotype drug resistance test PT
    20.1 10018065 - General disorders and administration site conditions 10048723 Multiple-drug resistance PT
    20.0 10018065 - General disorders and administration site conditions 10059866 Drug resistance PT
    20.0 100000004862 10004052 Bacterial resistance LLT
    20.0 100000004862 10038637 Resistance bacterial LLT
    20.1 100000004862 10028152 Multi-antibiotic resistance LLT
    20.0 10022891 - Investigations 10070974 Antibiotic resistance test LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2006-004784-58 Sponsor Protocol Number: MRI-0143 Start Date*: 2007-06-22
    Sponsor Name:University of Leuven
    Full Title: Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011401 Crohn's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) 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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