Empirical oral AntibioticS for possible UTI in well appearing Young febrile infants (EASY)
Research type
Research Study
Full title
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.
IRAS ID
1008782
Contact name
Thomas Waterfield
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
ISRCTN Number
ISRCTN10907780
Research summary
Research Summary:
Children between 1 and 3 months of age with a fever (raised body temperature) commonly undergo blood and urine tests to check for infection. They are admitted to hospital for a minimum of 36 to 48 hours to wait for results of their laboratory tests for infection and given intravenous antibiotics "just in case" while waiting for these results. Laboratory tests for infection involve watching to see if bacteria grow in the blood and urine samples over a period of 36 to 48 hours. As well as these slow tests for infection, babies will usually also have some rapid tests done on a blood sample (that take a few hours) which are used to help assess how unwell a baby is.
The most common infection requiring treatment with antibiotics, in babies aged 1 to 3 months is a urinary tract infection (UTI). These infections usually respond quickly to antibiotic treatment but can be difficult to diagnose. When doctors are unsure if there is a UTI, they often give intravenous antibiotics until the results of the laboratory tests for infection are available, which is typically 36 to 48 hours later.
Research has shown that babies aged between 1 and 3 months who appear well and have reassuring results from the rapid blood tests can be treated with oral antibiotics. Likewise, several international guidelines have been published that recommend oral antibiotics as first-line treatment for infants with a suspected UTI.
The aim of the EASY study is to determine if babies with a suspected UTI can be treated with oral antibiotics whilst they wait for their laboratory results. This approach has the potential to reduce the need for painful procedures such as injections, reduce hospital admissions with its associated stress for parents/guardians and reduce healthcare costs. We aim to recruit just under 600 patients to the study over the next three years from hospitals across the UK.Summary of Results:
Between May 2024 and March 2025, 27 babies were enrolled—only 27% of the target number. The study procedures were followed well, and no babies developed meningitis. Two babies had bacteria in their blood (one in each group), but both recovered without complications. Babies who received oral antibiotics spent less time in hospital and their parents took less time off work.
Although the study was carried out successfully, it was difficult to recruit enough participants. This means a larger trial comparing oral and IV antibiotics may not be practical in this setting.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0426
Date of REC Opinion
24 Jan 2024
REC opinion
Further Information Favourable Opinion