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Clinical trials for Carbapenemase

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    6 result(s) found for: Carbapenemase. Displaying page 1 of 1.
    EudraCT Number: 2012-000726-21 Sponsor Protocol Number: D4280C00006 Start Date*: 2012-09-11
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant G...
    Medical condition: cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10046574 Urinary tract infection NOS LLT
    14.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) GR (Completed) BG (Completed) HU (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000449-65 Sponsor Protocol Number: Desprobioxa Start Date*: 2014-07-07
    Sponsor Name:Fundacion para La Investigación Biomédica Hospital Universitario La Paz (FIBHULP)
    Full Title: PILOT STUDY OF the EFFECTIVENESS of PROBIOTICS and LACTITOL for the INTESTINAL Decolonization of PEOPLE CARRIERS of Klebsiella pneumoniae producers of carbapenemase OXA-48 TYPE: STUDIO DESPROBIOXA
    Medical condition: Intestinal Decolonization
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10069718 Bacterial colonization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003727-22 Sponsor Protocol Number: CER13266 Start Date*: 2015-05-26
    Sponsor Name:Geneva University Hospitals
    Full Title: A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carr...
    Medical condition: Intestinal colonization with extended-spectrum beta-lactamse or carbapenemase producing enterobacteriaceae
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    18.1 100000004862 10069718 Bacterial colonization LLT
    18.1 100000004862 10028152 Multi-antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001396-16 Sponsor Protocol Number: OP0595-6 Start Date*: 2023-07-07
    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 10021881 - Infections and infestations 10080628 Complicated urinary tract infection LLT
    20.1 10021881 - Infections and infestations 10079985 Uncomplicated pyelonephritis LLT
    21.1 10021881 - Infections and infestations 10081414 Ventilator associated bacterial pneumonia LLT
    20.1 10021881 - Infections and infestations 10079983 Complicated intra-abdominal infection LLT
    21.1 10021881 - Infections and infestations 10081416 Hospital acquired bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Ongoing) GR (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001618-41 Sponsor Protocol Number: FERARO Start Date*: 2020-04-14
    Sponsor Name:Guy's and St Thomas NHS Foundation Trust
    Full Title: FERARO: A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms
    Medical condition: Gastrointestinal colonisation and infection with Extended Spectrum Beta-lactamase (ESBL) producing Enetrobacteriales and Carbapenemase Producing Enetrobacteriales
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10004052 Bacterial resistance LLT
    20.1 10021881 - Infections and infestations 10034133 Pathogen resistance PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-001997-18 Sponsor Protocol Number: ACHN-490-007 Start Date*: 2014-02-25
    Sponsor Name:Achaogen, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriace...
    Medical condition: Bloodstream infections (BSI) and nosocomial pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Prematurely Ended) IT (Completed) DE (Completed) FR (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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