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Clinical trials for Enterobacterales

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3 result(s) found for: Enterobacterales. Displaying page 1 of 1.
    EudraCT Number: 2023-000052-38 Sponsor Protocol Number: FOSFO3GCRE Start Date*: 2023-06-26
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Intravenous Fosfomycin in hospitalized patients with complicated urinary tract infections due to Third-generation cephalosporinresistant Enterobacterales.
    Medical condition: urinary tract infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10046849 UTI symptoms LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005738-13 Sponsor Protocol Number: TPLBIS20 Start Date*: 2021-02-16
    Sponsor Name:Region Skåne
    Full Title: Pivmecillinam with Amoxicillin/clavulanic acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales.
    Medical condition: Urinary tract infection and/or bacteremia caused by extended spectrum beta-lactamases-producing Enterobacterales
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001396-16 Sponsor Protocol Number: OP0595-6 Start Date*: 2023-03-29
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Ur...
    Medical condition: Complicated urinary tract infection (cUTI), acute uncomplicated pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004862 10080628 Complicated urinary tract infection LLT
    20.1 100000004862 10079985 Uncomplicated pyelonephritis LLT
    21.1 100000004862 10081414 Ventilator associated bacterial pneumonia LLT
    20.1 100000004862 10079983 Complicated intra-abdominal infection LLT
    21.1 100000004862 10081416 Hospital acquired bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SK (Trial now transitioned) GR (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing)
    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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