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Clinical trials for aztreonam-avibactam

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   44366   clinical trials with a EudraCT protocol, of which   7389   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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    3 result(s) found for: aztreonam-avibactam. Displaying page 1 of 1.
    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: 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: 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
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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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