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Clinical trials for Drug resistant tuberculosis

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
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    • 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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    44 result(s) found for: Drug resistant tuberculosis. Displaying page 1 of 3.
    1  2  3  Next»
    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: 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: 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: 2019-002514-40 Sponsor Protocol Number: CISTA-TB Start Date*: 2019-10-31
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Phase II study on the safety and efficacy of cysteamine in association with standard tuberculosis therapy for the treatment of patients with pulmonary tuberculosis: a new therapy for tuberculosis d...
    Medical condition: Pulmonary Mycobacterium tuberculosis infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10037440 Pulmonary tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004295-18 Sponsor Protocol Number: DRTB-HDT Start Date*: 2022-11-21
    Sponsor Name:The Aurum Institute
    Full Title: A randomized controlled trial of two adjunctive host-directed therapies in rifampin-resistant tuberculosis (DRTB-HDT)
    Medical condition: Rifampin-resistant pulmonary tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10037440 Pulmonary tuberculosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001438-20 Sponsor Protocol Number: ASSTBS-FARM-INF_ITL-2021 Start Date*: 2021-05-10
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: Randomized controlled trial on daily Rifampicin for Four Months Compared with daily Rifampicin/Isoniazid for Three Months for the Treatment of Tuberculosis Infection among migrants: Completion Rate...
    Medical condition: Tuberculosis Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10065048 Latent tuberculosis PT
    20.0 10021881 - Infections and infestations 10065048 Latent tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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: 2008-005107-26 Sponsor Protocol Number: 242-07-208 Start Date*: 2009-04-08
    Sponsor Name:Otsuka Pharmaceutical Development and Commercialization, Inc.
    Full Title: A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up t...
    Medical condition: Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037440 Pulmonary tuberculosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed)
    Trial results: View results
    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: 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: 2013-000750-21 Sponsor Protocol Number: 12/0426 Start Date*: 2013-12-18
    Sponsor Name:University College London
    Full Title: The HALT-LTBI study: Phase IV, multi-site, unblinded, randomised trial of prophylactic daily rifampicin/isoniazid vs. weekly rifapentine/isoniazid for latent tuberculosis infection (LTBI)
    Medical condition: Latent tuberculosis infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10065048 Latent tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000850-36 Sponsor Protocol Number: 201600136 Start Date*: 2017-05-01
    Sponsor Name:Archivel Farma S.L.
    Full Title: Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculos...
    Medical condition: The medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and Isoniazid
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000358-13 Sponsor Protocol Number: A3921187 Start Date*: 2014-12-04
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATO...
    Medical condition: Moderately to severely active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) EE (Completed) LT (Completed) LV (Completed) GB (Completed) ES (Completed) PL (Completed) BG (Completed) RO (Completed) DE (Completed) HR (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: 2013-003177-99 Sponsor Protocol Number: A3921133 Start Date*: 2014-07-10
    Sponsor Name:Pfizer Inc.
    Full Title: PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SE (Completed) FI (Completed) NL (Completed) SK (Completed) GB (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004473-25 Sponsor Protocol Number: 242-12-232 Start Date*: 2018-09-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Pat...
    Medical condition: Pediatric patients with multidrug-resistant tuberculosis (MDRTB) who are receiving an optimized background regimen (OBR) of Antituberculosis Drugs
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004620-38 Sponsor Protocol Number: 242-12-233 Start Date*: 2019-01-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therap...
    Medical condition: Pediatric patients with multidrug-resistant tuberculosis (MDR-TB) who are receiving an optimized background regimen (OBR) of antituberculosis drugs
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002018-29 Sponsor Protocol Number: A3921165 Start Date*: 2020-12-09
    Sponsor Name:Pfizer Inc.
    Full Title: EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
    Medical condition: Systemic Juvenile Idiopathic Arthritis (sJIA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10079454 Systemic juvenile idiopathic arthritis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) PL (Completed) DE (Completed) BE (Completed) IT (Completed) NL (Prematurely Ended) SE (Prematurely Ended) HU (Completed)
    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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