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Clinical trials for Primary 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   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.
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    181 result(s) found for: Primary tuberculosis. Displaying page 1 of 10.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 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: 2019-002063-95 Sponsor Protocol Number: ASST-ITL-FARMA-INFE-2019 Start Date*: 2020-05-29
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: A Phase 3, Open, Randomized controlled trial on Completion Rate of daily Rifapentine/Isoniazid for One Month Compared with Daily Rifampicin/Isoniazid for Three Months for the Treatment of Latent Tu...
    Medical condition: latent 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 (Prematurely Ended)
    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: 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: 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: 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: 2022-000632-27 Sponsor Protocol Number: PORT-01 Start Date*: 2022-08-03
    Sponsor Name:Radboud University Medical Center
    Full Title: Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 2013-001184-24 Sponsor Protocol Number: SXT8469 Start Date*: 2013-08-20
    Sponsor Name:UMCG
    Full Title: Pharmacokinetic Parameters of 960 mg Co-trimoxazole Once Daily in Patients with Tuberculosis
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002000-31 Sponsor Protocol Number: FSJD-ISON-2016 Start Date*: 2016-09-21
    Sponsor Name:FUNDACIÓ SANT JOAN DE DÉU
    Full Title: Open clinical trial phase IIa to study the isoniazid suspension absoption of 10mg/ml for the tuberculosis infection treatment in patients under the age of 6
    Medical condition: tuberculosis infection in patients under the age of 6
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003420-38 Sponsor Protocol Number: PPD1 Start Date*: 2007-12-28
    Sponsor Name:Umeå University
    Full Title: The effect of Rapydan lidocain/tetracain patch on pain-response and reproducibilty in Tuberculin test
    Medical condition: Pain response to intradermal injection of tuberculin.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064882 Procedural pain LLT
    9.1 10044726 Tuberculin test LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-023189-27 Sponsor Protocol Number: RG-10-179 Start Date*: 2011-01-20
    Sponsor Name:University of Birmingham
    Full Title: The pharmacogenetics of vitamin D response in tuberculosis
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004444-29 Sponsor Protocol Number: RID-TB:Treat Start Date*: 2020-11-25
    Sponsor Name:University College London
    Full Title: An open-label, multi-centre, randomised controlled trial evaluating the effects of short-course rifapentine-based regimens and additional adherence support on LTBI treatment adherence and completio...
    Medical condition: Latent Tuberculosis infection (LTBI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10065048 Latent tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003567-20 Sponsor Protocol Number: A101A Start Date*: 2017-04-21
    Sponsor Name:Dept of Infectious Diseases, Aarhus University Hospital
    Full Title: A randomised controlled trial of a 12-dose rifapentine and isoniazid (RPT+INH) regimen using direct observed therapy (DOT) versus 6 months of daily isoniazid for latent tuberculosis infection (LTBI...
    Medical condition: Latent tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003721-25 Sponsor Protocol Number: High-shortRP Start Date*: 2020-02-03
    Sponsor Name:Region Östergötland
    Full Title: Randomized prospective phase II clinical trial investigating pharmacokinetics and safety aspects of higher doses of rifampicin and pyrazinamide in an shortened tuberculosis treatment compared to st...
    Medical condition: Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (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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