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Clinical trials for Beta-lactam resistance

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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    13 result(s) found for: Beta-lactam resistance. Displaying page 1 of 1.
    EudraCT Number: 2017-004677-14 Sponsor Protocol Number: DIABOLO Start Date*: 2018-03-09
    Sponsor Name:Erasmus MC
    Full Title: Dose IndividualizAtion of Beta-lactam and fluOroquinoLone AntiBiotics in ICU patients: to TDM or not to TDM and the effects on Outcome (DIABOLO-study)
    Medical condition: ICU patients with infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006908-32 Sponsor Protocol Number: PNEUMONOVA Start Date*: 2022-07-01
    Sponsor Name:Sonia Luque Pardos
    Full Title: Intrapulmonary penetration of ceftolozane / tazobactam and ceftazidime / avibactam administered in continuous infusion in critically ill patients with nosocomial pneumonia
    Medical condition: Nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000809-36 Sponsor Protocol Number: CAP-IT Start Date*: 2016-09-30
    Sponsor Name:Medical Research Council Clinical Trials Unit at UCL
    Full Title: Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia (CAP): a randomised controlled trial.
    Medical condition: Pneumonia
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004211-30 Sponsor Protocol Number: 2005-23 Start Date*: 2005-10-17
    Sponsor Name:The Norwegian Radium Hospital
    Full Title: Penicillin G and an aminoglycoside versus meropenem as initial empiric antibiotic therapy in lymphoma and leukemia patients with febrile neutropenia
    Medical condition: Lymphoma and leukemia patients with febrile neutropenia
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (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)
    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: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003529-13 Sponsor Protocol Number: 010617 Start Date*: 2017-10-19
    Sponsor Name:Thomas Benfield
    Full Title: Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacterermia: A randomized, non-blinded, non-inferiority interventional study
    Medical condition: Staphylococcus aureus bacteremia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10058887 Staphylococcus aureus bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000066-62 Sponsor Protocol Number: 7655A-013 Start Date*: 2015-08-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Im...
    Medical condition: imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infect...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) RO (Completed) LT (Completed) GR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-000246-34 Sponsor Protocol Number: 7655A-014 Start Date*: 2015-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/T...
    Medical condition: Treatment for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) BG (Completed) PT (Completed) LT (Completed) FR (Completed) ES (Completed) HR (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000338-20 Sponsor Protocol Number: MK-7655A-021 Start Date*: 2019-06-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Tha...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) Outside EU/EEA ES (Completed) BG (Completed) GR (Completed) NO (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000404-15 Sponsor Protocol Number: 34666 Start Date*: 2019-04-29
    Sponsor Name:Thomas Benfield
    Full Title: Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
    Medical condition: Community-acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    22.1 10021881 - Infections and infestations 10035725 Pneumonia NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    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
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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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