| 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 |
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Recruitment
Recruitment Target 584 Date Open to Recruitment 20th May 2024 Recruitment 2 as of July 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.
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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