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Clinical trials for Aztreonam

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 ).  
     
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Study N° 18554-126 : Comparative evaluation of aztreonam and ampicillin versus amikacin and ampicillin treatment for neonatal bacterial infections (report on protocol 18554-126, manuscript submitted for publication in the Journal of Pediatric Infectious Diseases). Study N° 18554-126 : Comparative evaluation of aztreonam and ampicillin versus amikacin and ampicillin treatment for neonatal bacterial infections (report on protocol 18554-126, manuscript submitted for publication in the Journal of Pediatric Infectious Diseases).
    Active substance: AMICACIN SULPHATE
    Study summary document link (including results):
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    Document reference: 46559
    Study title: Comparative evaluation of aztreonam and ampicillin versus amikacin and ampicillin treatment for neonatal bacterial infections (report on protocol 18554-126, manuscript submitted for publication in the Journal of Pediatric Infectious Diseases).
    Active substance: AMPICILLIN
    Study summary document link (including results):
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    Document reference: 46640
    Study title: Aztreonam - pediatric supplement (patient doses in the 2-12 year old age group).
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46692
    Study title: Comparative evaluation of aztreonam and ampicillin versus amikacin and ampicillin treatment for neonatal bacterial infections
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46685
    Study title: Comparative evaluation of aztreonam and tobramycin plus azlocillin in pulmonary exacerbations of cystic fibrosis
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46686
    Study title: Evaluations of efficacy of aztreonam in treatment of cystic fibrosis
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46687
    Study title: Protocol 18554-62, report of a single intravenous-dose pharmacokinetic and safety study of aztreonam in pediatric patients (revised page to Appendix D 856710103).
    Active substance: AZTREONAM
    Study summary document link (including results): Statement aztreonam-pediatric-studies-31238-1.pdf
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    Document reference: 46689
    Study title: Protocol 18554-62, report of a single intravenous-dose pharmacokinetic and safety study of aztreonam in pediatric patients (revised page to Appendix D 856710103).
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46691
    Study title: Report of a single intravenous-dose pharmacokinetic intravenous-dose pharmacokinetic and safety study of aztreonam in pediatric patients given 30 or 50 mg/kg (report on protocols 18554-52 and Addendum A, revised pages in 856771038).
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46690
    Study title: Report of a study of aztreonam pharmacokinetics in premature pediatric patients with suspected gram-negative infections (report on protocol 18554-58 Addendum D).
    Active substance: AZTREONAM
    Study summary document link (including results):
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    Document reference: 46688
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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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