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Clinical trials for Carbapenem-resistant enterobacteriaceae

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    7 result(s) found for: Carbapenem-resistant enterobacteriaceae. Displaying page 1 of 1.
    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: 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: 2012-004819-31 Sponsor Protocol Number: 1787/12 Start Date*: 2013-07-08
    Sponsor Name:RADBOUD UNIVERSITY NIJMEGEN MEDICAL CENTER
    Full Title: Multicenter open-label RCT to compare colistin alone vs. colistin plus meropenem
    Medical condition: INFECTIONS DUE TO CARBAPENEM RESISTENT GRAM NEGATIVE BACTERIA
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10004047 Bacterial infections NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) GR (Completed)
    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: 2022-002636-31 Sponsor Protocol Number: APHP211034 Start Date*: 2022-09-15
    Sponsor Name:Assistance Publique Hôpitaux de Paris/DRCI
    Full Title: Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the in...
    Medical condition: severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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: 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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