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Clinical trials for Beta lactamase

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 ).  
     
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    13 result(s) found for: Beta lactamase. Displaying page 1 of 1.
    EudraCT Number: 2013-002922-21 Sponsor Protocol Number: FOREST Start Date*: 2014-05-07
    Sponsor Name:FISEVI
    Full Title: Randomized, phase III, multicentre, open-labelled clinical trial, to evaluate the efficacy of fosfomycin vs meropenem in the treatment of bacteremic urinary tract infection caused by Escherichia co...
    Medical condition: Bacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL).
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10052238 Escherichia urinary tract infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    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: 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: 2014-003727-22 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: 2019-002829-29 Sponsor Protocol Number: ANRS174 Start Date*: 2019-12-12
    Sponsor Name:INSERM ANRS
    Full Title: Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP)
    Medical condition: MSM with at least 6-month experience with PrEP (Pre-Exposure Prophylaxis)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004044-28 Sponsor Protocol Number: AKF-396 Start Date*: 2020-12-18
    Sponsor Name:University of Southern Denmark
    Full Title: Flucloxacillin as an inducer of CYP-enzymes
    Medical condition: Healthy volunteers. (Flucloxacillin is used against infections caused by beta-lactamase-producing organisms) Testing for drug-drug interactions caused by flucloxacillin
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10004035 Bacterial infection due to staphylococcus aureus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003814-37 Sponsor Protocol Number: AKF-400 Start Date*: 2021-11-29
    Sponsor Name:Odense University Hosipital
    Full Title: The effect of dicloxacillin on oral absorption of drugs
    Medical condition: Healthy volunteers. (Dicloxacillin is used against infections caused by beta-lactamase-producing organisms) Testing for drug-drug interactions caused by dicloxacillin.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10004035 Bacterial infection due to staphylococcus aureus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    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: 2016-001054-17 Sponsor Protocol Number: PHRN15-SE/AMIKINHAL Start Date*: 2017-01-27
    Sponsor Name:CHRU de Tours
    Full Title: Double-blinded multicenter randomized controlled trial comparing inhaled amikacin versus placebo to prevent ventilator associated pneumonia
    Medical condition: Patient with mechanical ventilation through an endotracheal tube
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001257-14 Sponsor Protocol Number: P160910J Start Date*: 2018-04-13
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Temocillin versus a carbapenem as initial intravenous treatment for extended-spectrum beta-lactamase related urinary tract infections, a non-inferiority study.TEMO-CARB
    Medical condition: -Hospitalized patient with complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054088 Urinary tract infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-002346-32 Sponsor Protocol Number: SB-2-004-005 Start Date*: 2015-11-27
    Sponsor Name:Synthetic Biologics, Inc.
    Full Title: A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Associated Diarrhea in Patients with a Diag...
    Medical condition: Prevention of Clostridium difficile infection (CDI), Clostridium difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired drug-re...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10006834 C.difficile diarrhea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-003179-32 Sponsor Protocol Number: ToL54304 Start Date*: 2016-02-03
    Sponsor Name:University Medical Center Utrecht
    Full Title: PREvention of Complications to Improve Outcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment.
    Medical condition: Stroke (ischaemic stroke or intracerebral hemorrhage)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    21.1 10029205 - Nervous system disorders 10022754 Intracerebral hemorrhage LLT
    22.1 10029205 - Nervous system disorders 10042244 Stroke LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) GR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004868-35 Sponsor Protocol Number: AT-301 Start Date*: 2018-08-23
    Sponsor Name:Allecra Therapeutics SAS
    Full Title: A Phase 3, Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Cefepime- AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Ur...
    Medical condition: Complicated urinary tract infections including acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10037597 Pyelonephritis acute PT
    20.0 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) ES (Completed) BG (Completed) SK (Completed) PL (Completed) HU (Completed) HR (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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