Empirical oral AntibioticS for possible UTI in well-appearing Young febrile infants (EASY)

Eligibility

Local study conflicts

• None

Inclusion Criteria:

• 29 to 90 days of age (Infants from their 29th day of life to their 90th day of life inclusive. Day of birth is day 1 of life)
• Suspected urinary tract infection (UTI) requiring treatment with antibiotics
• History of fever as defined as temperature ≥38°C measured by any method OR likely fever in last 24 hours including subjective fever reported by caregiver
• Abnormal urinalysis defined as either:
  
  • Abnormal urinary dipstick test (leucocyte esterase ≥1+, or nitrite ≥Trace)
    

  Or

  • Abnormal urine microscopy (≥5 white cells per high-power field in centrifuged urine or ≥10 white cells per mm3 in un-centrifuged urine or bacteriuria with any bacteria per high power field)

Exclusion Criteria:

• Born at <30 weeks gestation
• Discharged from hospital more than 7 days after birth
• Required re-admission to hospital after birth for more than 24 hours
• Known or suspected structural renal abnormality
• Evidence of sepsis and/or meningitis (appear unwell, shock, hypotension, altered mental state, bulging fontanelle, lumbar puncture suggestive of bacterial meningitis)
• Received vaccination within 48 hours of attendance
• Sodium < 128mmol/l on lab or blood gas sample
• Potassium > 6.5 mmol/l on lab sample
• Plasma creatinine > 50 micromol/l
• Inability to tolerate oral medication
• Urine sample was not sent for culture
• Received additional antibiotics (with the exception of the parenteral antibiotic administered within 24 hours of hospital attendance)
• Declined consent for participation

If the patient is eligible:

Step by Step Guide to Recruitment:

In standard working hours; 9-5

• Please contact the ED Research Team when eligible patients arrive in ED:
  Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907

Out of hours and weekends:

Essential first steps

1. Find the next Screening number in the EASY Yellow Folder containing the paperwork.
2. Assess Eligibility (NB: only a Consultant can determine if a baby is well enough – point 5 of inclusion criteria – and this must be documented in the notes
3. Pick up patient pack from the corner bookshelf in the clinical workstation:
   
   • Patient information sheet
   • Consent form
   • Clear plastic folder (all questionnaires parents need to complete for the trial)
   • Questionnaire on consent

Consenting the patient formally

• Now approach the parents
• Provide the parents with the PIS and consent form to complete
• If they decline – offer them the questionnaire on consent – and record the screening number

Randomisation procedure

• Randomise - Login (abdn.ac.uk) (please keep your username and password somewhere readily available)

Carrying out the intervention:

• Document in the notes using .EASYRANDOMISATION and inform the paediatric team

Documentation

• Complete the PedsQL Infant Questionnaire (in the pack)
• The small A5 clear pack contains questionnaires to be completed by the parents at 36 hours, on day 7 and on day 28. Write the screening and randomisation number on each pack envelope and each questionnaires before giving this to the parents.
• Give Parents the pack
• Place the completed consent form and questionnaire in the post box behind reception

Disposition and follow-up:

If admitted:

• Any necessary follow will be arranged in working hours by the research team.

If discharged:

• Followed up at 24 hours, 48 hours, 7 days and 28 days by us with a phone call; +/- a 6 week follow up at clinicians discretion.

Links for further information:

Link to information for clinicians (links to protocol embedded within)

Link to local training