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Clinical trials for Aztreonam lysine

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
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    • 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 ).  
     
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    13 result(s) found for: Aztreonam lysine. Displaying page 1 of 1.
    EudraCT Number: 2018-001590-24 Sponsor Protocol Number: 01.01.18 Start Date*: 2019-03-21
    Sponsor Name:University of Dundee [...]
    1. University of Dundee
    2. NHS Tayside
    Full Title: A Trial of the Safety, Tolerability and Efficacy of 2 doses of Cayston (Aztreonam Lysine) compared to placebo in participants with bronchiectasis.
    Medical condition: Bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2015-000396-26 Sponsor Protocol Number: EA-US-205-0111 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disea...
    Medical condition: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002726-39 Sponsor Protocol Number: D4910C00009/C3601001 Start Date*: 2016-02-25
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abd...
    Medical condition: Complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    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: 2013-004295-35 Sponsor Protocol Number: LCI-OUT Start Date*: 2014-04-30
    Sponsor Name:Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)
    Full Title: Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study
    Medical condition: Chronic lung P. Aeruginosa Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000395-97 Sponsor Protocol Number: GS-US-205-0117 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc. [...]
    1. Gilead Sciences, Inc.
    2. Gilead Sciences Pty Ltd
    3. Gilead Sciences Canada, Inc.
    Full Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (A...
    Medical condition: Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003865-32 Sponsor Protocol Number: AZLI-2018-AR Start Date*: 2019-01-22
    Sponsor Name:Alejandro Rodriguez Oviedo ‐ Critical Care Department – Hospital Universitario de Tarragona Joan XXIII
    Full Title: Efficacy, safety and pharmacokinetics profile of nebulized Aztreonam Lysine (AZLI) for prevention of Gram negative pneumonia in heavily colonized mechanically ventilated patients: AZLIS
    Medical condition: Gram negative pneumonia in heavily colonized mechanically ventilated patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035725 Pneumonia NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2011-001362-18 Sponsor Protocol Number: GS-US-205-0160 Start Date*: 2012-03-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chron...
    Medical condition: cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10068288 Cystic fibrosis pulmonary exacerbation LLT
    14.1 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002749-42 Sponsor Protocol Number: GS-US-205-1850 Start Date*: 2017-09-18
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution...
    Medical condition: Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10068288 Cystic fibrosis pulmonary exacerbation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) AT (Completed) FR (Completed) DE (Completed) ES (Completed) NL (Completed) IT (Completed) GR (Completed) DK (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001255-36 Sponsor Protocol Number: GS-US-205-0162 Start Date*: 2012-01-16
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cyst...
    Medical condition: Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    14.1 10021881 - Infections and infestations 10068288 Cystic fibrosis pulmonary exacerbation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FR (Ongoing) AT (Completed) ES (Completed) NL (Completed) IE (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004544-38 Sponsor Protocol Number: C3601009 Start Date*: 2020-07-03
    Sponsor Name:Pfizer Inc.
    Full Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INF...
    Medical condition: SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021804 Infection bacterial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-004277-26 Sponsor Protocol Number: GS-US-205-0110 Start Date*: 2008-04-29
    Sponsor Name:Gilead Sciences Inc
    Full Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Int...
    Medical condition: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) GB (Completed) IE (Completed) DK (Completed) DE (Completed) NL (Completed) IT (Completed) PT (Completed) AT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-000397-36 Sponsor Protocol Number: EA-US-205-0122 Start Date*: 2015-02-03
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk ...
    Medical condition: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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