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Clinical trials for Antibiotic-resistant bacteria

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    9 result(s) found for: Antibiotic-resistant bacteria. Displaying page 1 of 1.
    EudraCT Number: 2010-023889-52 Sponsor Protocol Number: AntiResDev-SWE Start Date*: 2011-01-18
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: Effects of Clindamycin and Ciprofloxacin administration on the emergence, prevalence and persistence of antibiotic-resistant bacteria in humans
    Medical condition: To assess the effect of ciprofloxacin and clindamycin administration on the proportions and types of cultivable antibiotic-resistant bacteria that emerge in the oropharynx, on the skin and in the...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017647-34 Sponsor Protocol Number: ANTIRESDEV Start Date*: 2010-03-29
    Sponsor Name:Helperby Therapeutics
    Full Title: Effect of minocycline and amoxicillin administration on the prevalence of antibiotic resistant bacteria and on the indigenous oral, faecal, cutaneous and nasal microbiotas.
    Medical condition: Amoxicillin and Minocycline are marketed antibiotic to fight bacterial infections.
    Disease: Version SOC Term Classification Code Term Level
    12 10002737 Antibiotic Resistant Strain SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2016-002388-33 Sponsor Protocol Number: ZKSJ0086 Start Date*: 2016-09-05
    Sponsor Name:Friedrich-Schiller-University Jena
    Full Title: Therapeutic drug monitoring (TDM) for personalized antibiotic treatment with piperacillin-tazobactam (PipTaz) in patients with febrile neutropenia after myelo-suppressive cytostatic chemotherapy
    Medical condition: Patients with febrile neutropenia after myelo-suppressive chemotherapy treated with piperacillin/tazobactam
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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: 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: 2008-005912-41 Sponsor Protocol Number: TMO-07001 Start Date*: 2010-05-04
    Sponsor Name:Belpharma SA/NV
    Full Title: Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom
    Medical condition: Patients presenting urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046571 Urinary tract infection LLT
    9.1 10002737 Antibiotic resistant strain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001521-25 Sponsor Protocol Number: NEOMERO-2 Start Date*: 2011-12-15
    Sponsor Name:FONDAZIONE PENTA ONLUS
    Full Title: Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase II trial
    Medical condition: Bacterial meningitis in children up to 90 days of age
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10004049 Bacterial meningitis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) GR (Completed) LT (Completed) ES (Completed) NL (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001515-31 Sponsor Protocol Number: NEOMERO-1 Start Date*: 2011-08-25
    Sponsor Name:FONDAZIONE PENTA ONLUS
    Full Title: EFFICACY, PHARMACOKINETICS AND SAFETY OF MEROPENEM IN INFANTS BELOW 90 DAYS OF AGE (INCLUSIVE) WITH CLINICAL OR CONFIRMED LATE-ONSET SEPSIS: A EUROPEAN MULTICENTER RANDOMISED PHASE III TRIAL
    Medical condition: late onset sepsis in the neonate and infant up to 90 days of age
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) GR (Completed) LT (Completed) ES (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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