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Clinical trials for CRE

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   44365   clinical trials with a EudraCT protocol, of which   7389   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    10 result(s) found for: CRE. Displaying page 1 of 1.
    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)
    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: 2014-000546-30 Sponsor Protocol Number: Rempex-506 Start Date*: 2015-04-21
    Sponsor Name:Rempex Pharmaceuticals, Inc.
    Full Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTERO...
    Medical condition: serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), complicated intra-abdominal infections (cIAI), hospital acquired bacterial pneumonia (HABP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10003999 Bacteremia LLT
    18.0 100000004862 10001032 Acute pyelonephritis LLT
    18.0 100000004862 10056570 Intra-abdominal infection LLT
    18.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    18.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) ES (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003048-11 Sponsor Protocol Number: GIPIT002 Start Date*: 2014-10-24
    Sponsor Name:GIPIT
    Full Title: FEcal transplant, a Dazzling debut to Eradicate colonization with eXtreme drug resistant bacteria?
    Medical condition: Patient harboring Extreme Drug Resistant (XDR) bacteria. Our trial try to eradicate this digestive tract colonization by performing a fecal transplantation.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004402-10 Sponsor Protocol Number: APHP180587 Start Date*: 2020-03-11
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Fecal transplantation to Eradicate Colonizing Emergent Superbugs
    Medical condition: Patients colonized with MDR-GNB (multi-drug resistant Gram Negative bacteria )
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10028152 Multi-antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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
    EudraCT Number: 2010-019873-13 Sponsor Protocol Number: 1200/002 Start Date*: 2010-06-07
    Sponsor Name:UCL Cliniques Universitaires Saint Luc
    Full Title: Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or Methotrexate Addendum protocol : Global gene expression...
    Medical condition: early rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10039075 Rheumatoid arthritis and associated conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001344-57 Sponsor Protocol Number: PENTALLO Start Date*: 2019-10-10
    Sponsor Name:GITMO GRUPPO ITALIANO PER IL TRAPIANTO DI MIDOLLO OSSEO, CELLULE STAMINALI EMOPOIETICHE E TERAPIA
    Full Title: Pentaglobin as early adjuvant treatment for febrile neutropenia in acute leukemia or allogeneic hematopoietic stem cell transplant patients colonized by carbapenem-resistant Enterobacteriaceae or P...
    Medical condition: The study will enroll consecutive adult patients suffering from acute leukemia candidate to intensive chemotherapy or patients with hematological cancers candidate to allogeneic transplant with a d...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10013120 Diseases of blood and blood-forming organs, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    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: 2017-002110-32 Sponsor Protocol Number: 10-0065 Start Date*: 2018-06-13
    Sponsor Name:Regents of the University of Michigan
    Full Title: DMID Protocol Number: 10-0065 OVERCOME Trial: Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli
    Medical condition: Blood stream Infection (BSI) and/or pneumonia due to extensively drug-resistant Gram-negative bacilli (XDR-GNB) including XDR-AB, CRE and XDR-PA
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    20.1 10021881 - Infections and infestations 10035701 Pneumonia gram-negative bacterial NOS LLT
    20.1 10021881 - Infections and infestations 10064977 Acinetobacter bacteremia LLT
    20.0 10021881 - Infections and infestations 10051190 Pneumonia Pseudomonas aeruginosa LLT
    20.0 10021881 - Infections and infestations 10035679 Pneumonia due to Escherichia coli (E. Coli) LLT
    20.0 10021881 - Infections and infestations 10054280 Escherichia coli bacteraemia LLT
    20.0 10021881 - Infections and infestations 10021860 Infection Pseudomonas aeruginosa LLT
    20.1 10021881 - Infections and infestations 10023456 Klebsiella pneumonia LLT
    20.0 10021881 - Infections and infestations 10058883 Klebsiella bacteremia LLT
    20.0 10021881 - Infections and infestations 10054218 Enterobacter pneumonia PT
    20.1 10021881 - Infections and infestations 10058884 Enterobacter bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) GR (Completed) IT (Completed)
    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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