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EASY

Trial Acronym EASY Study
Clinical Area Paediatrics
Trial Title A multi-centre randomised, non-inferiority trial comparing parenteral antibiotics with oral antibiotics for the management of suspected urinary tract infections in well appearing young febrile infants.
Status Open to Recruitment
Trial Registration https://www.isrctn.com/ISRCTN10907780

  • Recruitment
    Recruitment Target 584
    Date Open to Recruitment 20th May 2024
    Recruitment 2 as of June 2024
    Date Closed to Recruitment Ongoing
  • Trial Design
    Trial Design A multicentre, randomised controlled, open-label, non-inferiority trial, comparing parenteral antibiotics with oral antibiotics for the management of suspected UTI in low risk infants.
    Study Aim

     

     

     

     

     

     

     

     

     

     

    To assess the clinical effectiveness and cost-consequence of early oral antibiotics in infants presenting to hospital with suspected UTI who appear well and are at low risk of complications.

    Study Objectives:

    1.  To determine if the clinical effectiveness of oral
    antibiotics pending urine culture results is non-inferior to parenteral antibiotics pending urine
    culture results in terms of treatment failure (i.e. the
    requirement for additional parenteral antibiotics)
    and a range of secondary outcomes.

    2.    To evaluate the impact of oral antibiotics on healthcare resource use, costs and selected outcomes via a cost-consequence analysis.

  • Chief Investigator
    Chief Investigator Dr Thomas Waterfield, Queen’s University Belfast
    Email T.Waterfield@qub.ac.uk
  • Sponsor & Funder
    Sponsor Belfast Health and Social Care Trust
    Funder

     

     

     

    National Institute for Health and Care Research

    Health Technology Assessment Programme; NIHR152733

    www.fundingawards.nihr.ac.uk/award/NIHR152733