Empirical oral AntibioticS for possible UTI in well appearing Young febrile infants (EASY)
Thomas Waterfield1,2, Ronan McMullan2, Mark D Lyttle3
1Queen's University Belfast, Belfast, Northern Ireland, UK.
Insights
This study found that oral antibiotics may be a viable alternative to intravenous antibiotics for treating urinary tract infections (UTIs) in low-risk infants, showing similar outcomes with added benefits of shorter hospital stays and reduced parental absence from work.
Area of Science:
- Pediatric infectious diseases
- Clinical trial methodology
- Antibiotic stewardship
Background:
- Urinary tract infections (UTIs) are common serious bacterial infections in febrile infants.
- Current UK guidelines favor parenteral antibiotics for infants under three months with suspected UTI.
- Evidence suggests oral therapy may be effective for low-risk infants.
Purpose of the Study:
- To determine if oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs in infants.
- To compare treatment failure, need for additional therapy, and secondary outcomes between oral and parenteral antibiotic groups.
- To assess the feasibility of conducting a larger trial on this treatment comparison.
Main Methods:
- A multicenter, randomized controlled, open-label, non-inferiority trial with an embedded internal pilot.
- Infants aged 29-90 days with suspected UTI and low risk of invasive bacterial infection were randomized.
- Participants received either oral antibiotics or standard intravenous (IV) antibiotics.
Main Results:
- 27 participants were recruited, achieving 27% of the pilot target.
- Oral therapy was associated with shorter hospital stays and reduced parental time off work.
- No cases of meningitis occurred; two cases of uncomplicated bacteraemia were reported.
Conclusions:
- Trial procedures were successfully implemented, demonstrating high protocol adherence.
- Recruitment challenges indicate that a larger randomized trial is not feasible in this setting.
- Oral antibiotics show promise for treating UTIs in low-risk infants, but further large-scale trials are needed.
Background:
Urinary tract infections (UTIs) are the most common serious bacterial infections in febrile infants. Current UK guidelines recommend parenteral antibiotics for infants under three months with suspected UTI, despite evidence supporting oral therapy in low-risk infants.
Objectives:
To assess whether oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs based on treatment failure, need for additional therapy, and secondary outcomes.
Design:
Multicentre, randomised controlled, open-label, non-inferiority trial with embedded internal pilot.
Setting:
Twenty one paediatric emergency departments and assessment units across the UK.
Participants:
Infants aged 29-90 days with suspected UTI, abnormal urinalysis, and low risk of invasive bacterial infection. Exclusion criteria included prematurity, prior hospitalisation, structural renal abnormalities, and clinical signs of sepsis or meningitis.
Interventions:
Participants were randomised 1:1 to receive either oral antibiotics or standard care with intravenous (IV) antibiotics for 36-48 hours pending urine culture results.
Main Outcome Measures:
The primary outcome was the requirement for additional parenteral antibiotics within seven days of randomisation. A range of secondary outcomes were also planned, including treatment failure, time to recovery, adverse events, antibiotic adherence, quality of life, family impact, and healthcare resource use.Feasibility outcomes collected during the internal pilot included recruitment rate, site activation, protocol adherence, and retention. Clinical outcomes were collected but not powered for formal comparison.
Results:
27 participants were recruited between 20 May 2024 and 13 March 2025 (which included the 6 month internal pilot), representing 27% of the pilot target. Protocol adherence was high, and no cases of meningitis occurred. Two cases of bacteraemia (one per randomised group) had uncomplicated clinical courses. Oral therapy was associated with shorter hospital stays and reduced parental time off work.
Conclusions:
While trial procedures were successfully implemented, recruitment challenges suggest that a larger randomised trial of this treatment comparison is not feasible in this setting.
Trial Management:
Northern Ireland Clinical Trials Unit (NICTU).
Trial Registration:
ISRCTN Clinical Trials Registry, ISRCTN10907780, Trial Dates 20 May 2024 to 13 March 2025.
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