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Clinical trials for Multidrug 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
  • 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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    15 result(s) found for: Multidrug resistant tuberculosis. Displaying page 1 of 1.
    EudraCT Number: 2010-022271-59 Sponsor Protocol Number: 242-09-213 Start Date*: 2011-07-19
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dos...
    Medical condition: Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10037443 Pulmonary tuberculosis, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed) LT (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: 2007-005229-31 Sponsor Protocol Number: 242-07-204 Start Date*: 2008-02-14
    Sponsor Name:Otsuka Pharmaceutical Development and Commercialization, Inc.
    Full Title: A Multi center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC-67683 in Patients with Pulmonary Sputum Cu...
    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: EE (Completed) LV (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: 2008-006765-82 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: 2009-014944-13 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: 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: 2015-004440-19 Sponsor Protocol Number: CLAM320B2202 Start Date*: 2016-03-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 30-month multicenter, phase 2b/3, randomized, open label trial to evaluate the efficacy and safety of clofazimine administered orally in addition to background regimen compared to background regi...
    Medical condition: Treatment of multidrug-resistant pulmonary tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10070578 Multidrug resistant tuberculosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended)
    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: 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: 2005-003312-29 Sponsor Protocol Number: UITB Estudio 28 Start Date*: 2006-05-17
    Sponsor Name:TB Investigation Unit of Barcelona
    Full Title: Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment TBTC/UITB Study 28
    Medical condition: To compare two treatments for pulmonary tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 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: 2017-003374-14 Sponsor Protocol Number: SAV008-01 Start Date*: 2018-04-06
    Sponsor Name:Savara ApS
    Full Title: An Open-label, non-controlled, multicenter, Pilot clinical Trial of Inhaled Molgramostim in subjects with Antibiotic-resistant non-tuberculosis mycobacterial (NTM) infection
    Medical condition: Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10062207 Mycobacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001733-16 Sponsor Protocol Number: A3921083 Start Date*: 2012-04-10
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE C...
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10011402 Crohn's disease (colon) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Prematurely Ended) ES (Completed) HU (Completed) GR (Completed) AT (Completed) CZ (Completed) NL (Completed) BG (Completed) HR (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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