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Clinical trials for Multidrug-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   44334   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    16 result(s) found for: Multidrug-resistant bacteria. Displaying page 1 of 1.
    EudraCT Number: 2020-000673-24 Sponsor Protocol Number: PHRC_N_2018_BAY Start Date*: 2021-04-15
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: Faecal microbiota transplantation for prevention of graft-versus-host sisease after allogeneic stem cell transplantation for haematological malignancies
    Medical condition: Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies. Faecal microbiota transplantation (FMT) will be assessed to prevent al...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003708-22 Sponsor Protocol Number: E2015-PK-USI-BMR-COLISTIN Start Date*: 2015-10-23
    Sponsor Name:Hospital Erasme
    Full Title: Colistin use in critically ill patients: pharmacokinetic population and pharmacodynamic studies, tolerance profil and risk of selection of resistance
    Medical condition: Patients in intensive care unit suffering of infection by multi-drug resistance bacteria treated by colistin
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10040054 Sepsis, bacteraemia, viraemia and fungaemia NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005738-13 Sponsor Protocol Number: TPLBIS20 Start Date*: 2021-02-16
    Sponsor Name:Region Skåne
    Full Title: Pivmecillinam with Amoxicillin/clavulanic acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales.
    Medical condition: Urinary tract infection and/or bacteremia caused by extended spectrum beta-lactamases-producing Enterobacterales
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000953-30 Sponsor Protocol Number: EPAAC Start Date*: 2019-07-25
    Sponsor Name:Uppsala University Hospital
    Full Title: Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers: a randomized clinical trail
    Medical condition: Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000910-12 Sponsor Protocol Number: HT011 Start Date*: 2020-07-01
    Sponsor Name:Helperby Therapeutics Ireland Limited
    Full Title: A Double-blinded, Parallel-group, Randomized, Active-controlled Phase 2 Clinical Trial to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous HY-001 Versus Standard Colis...
    Medical condition: complicated urinary tract infection (cUTI).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000850-36 Sponsor Protocol Number: 201600136 Start Date*: 2017-05-01
    Sponsor Name:Archivel Farma S.L.
    Full Title: Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculos...
    Medical condition: The medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and Isoniazid
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002742-68 Sponsor Protocol Number: C3601002 Start Date*: 2018-04-24
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3 Prospective, Randomized, Multicenter, Open-Label, Central Assessor-Blinded, Parallel Group, Comparative Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (AT...
    Medical condition: Complicated intra-abdominal infection (cIAI) and hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Ongoing) BG (Completed) GR (Completed) HR (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-001324-33 Sponsor Protocol Number: APHP200392 Start Date*: 2020-04-09
    Sponsor Name:ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)
    Full Title: Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized contr...
    Medical condition: Severe confirmed COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000735-41 Sponsor Protocol Number: 2015_66 Start Date*: 2016-09-06
    Sponsor Name:CHRU LILLE
    Full Title: Antimicrobial treatment in patients with ventilator-associated tracheobronchitis: a prospective randomized placebo-controlled double-blind multicenter trial
    Medical condition: ventilator-associated pneumonitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10047263 Ventilation pneumonitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001048-73 Sponsor Protocol Number: BAY41-6551/13084 Start Date*: 2013-07-25
    Sponsor Name:Bayer AG
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati...
    Medical condition: Gram-negative pneumonia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10035701 Pneumonia gram-negative bacterial NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-000914-76 Sponsor Protocol Number: 1409R2121 Start Date*: 2014-11-24
    Sponsor Name:Shionogi Inc.
    Full Title: A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Unc...
    Medical condition: Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative Pathogens
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) IT (Completed) ES (Completed) DE (Completed) PL (Completed) RO (Completed) HR (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-003048-21 Sponsor Protocol Number: Uni-Köln-1667 Start Date*: 2014-03-10
    Sponsor Name:University of Cologne
    Full Title: CONTROLING INTESTINAL COLONIZATION OF HIGH-RISK PATIENTS WITH EXTENDED- SPECTRUM BETALACTAMASE PRODUCING ENTEROBACTERIACEAE (ESBL-E) – A RANDOMIZED TRIAL (CLEAR)
    Medical condition: Immunocompromised patients at high risk of bloodstream infections with colonizing bacteria.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10066481 Hematological malignancy LLT
    16.1 100000004865 10067862 Allogeneic stem cell transplantation LLT
    16.1 100000004870 10054990 Immunodeficiency secondary to organ transplantation LLT
    16.1 100000004870 10021458 Immunodeficiency secondary to transplantation chemotherapy LLT
    16.1 100000004870 10021452 Immunodeficiency secondary to chemotherapy (excl corticosteroids) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000450-21 Sponsor Protocol Number: MONS4STRAT Start Date*: 2018-04-09
    Sponsor Name:Fundación Investigación Biomédica Hospital Ramón y Cajal
    Full Title: Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated,...
    Medical condition: Nosocomial pneumonia or severe tracheobronchitis caused by Gram-negative pathogens in subjects that requiring mechanical ventilation.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003847-10 Sponsor Protocol Number: SHORTENII Start Date*: 2022-01-12
    Sponsor Name:Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
    Full Title: Efficacy and safety of 7 versus 14 days of antibiotic treatment for Pseudomonas aeruginosa bacteraemia: a multicentre, randomized clinical trial (SHORTEN-2) with a DOOR/RADAR analysis
    Medical condition: Adult patients with bloodstream infections produced by Pseudomonas aeruginosa.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    22.1 10021881 - Infections and infestations 10037132 Pseudomonal infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002327-15 Sponsor Protocol Number: APHP180596 Start Date*: 2023-03-15
    Sponsor Name:APHP
    Full Title: Beta-lactam Intermittent versus Continuous infusion and Combination antibiotic therapy in Sepsis
    Medical condition: Beta-lactam Intermittent vs Continuous infusion and Combination antibiotic therapy in Sepsis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-000906-35 Sponsor Protocol Number: BAY41-6551/13085 Start Date*: 2008-11-28
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati...
    Medical condition: Gram-negaive pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) NL (Completed) BE (Completed) ES (Completed) FR (Completed) LV (Prematurely Ended) GR (Completed) PT (Completed) IT (Prematurely Ended) PL (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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