Empirical oral AntibioticS for possible urinary tract infection (UTI) in well-appearing Young febrile infants (EASY)
- Conditions
- rinary tract infection (UTI)Infections and Infestations
- Registration Number
- ISRCTN10907780
- Lead Sponsor
- Belfast Health and Social Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 584
Current inclusion criteria as of 30/04/2024:
1. 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)
2. Suspected urinary tract infection (UTI) requiring treatment with antibiotics
3. 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
4. Abnormal urinalysis defined as: (1) abnormal urinary dipstick test (leucocyte esterase =1+, or nitrite =Trace) OR (2) 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)
5. Well on global clinical assessment using the paediatric assessment triangle* assessed by a consultant grade doctor.
_____
Previous inclusion criteria:
1. 29 to 90 days of age (infants from their 29th day of life to their 90th day of life inclusive)
2. Suspected urinary tract infection (UTI) requiring treatment with antibiotics
3. 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 the caregiver
4. Abnormal urinalysis defined as: (1) abnormal urinary dipstick test (leucocyte esterase =1+, or nitrite =Trace) OR (2) 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)
5. Well on global clinical assessment using the paediatric assessment triangle*[28]
6. C-Reactive Protein <20mg/l and Absolute Neutrophil Count >500 and <5200/mm3
Current exclusion criteria as of 30/04/2024:
1. Born at <30 weeks gestation
2. Discharged from hospital more than 7 days after birth
3. Required re-admission to hospital after birth for more than 24 hours
4. Known or suspected structural renal abnormality
5. Evidence of sepsis and/or meningitis (appear unwell, shock, hypotension, altered mental state, bulging fontanelle, lumbar puncture suggestive of bacterial meningitis)
6. Received vaccination within 48 hours of attendance
7. Sodium < 128mmol/l on lab or blood gas sample
8. Potassium > 6.5 mmol/l on lab sample
9. Plasma creatinine > 50 micromol/l
10. Inability to tolerate oral medication
11. Urine sample was not sent for culture
12. Received additional antibiotics (with the exception of the parenteral antibiotic administered within 24 hours of hospital attendance)
13. Declined consent for participation
_____
Previous exclusion criteria:
1. Born at <30 weeks gestation
2. Discharged from hospital more than 7 days after birth
3. Required re-admission to hospital after birth for more than 24 hours
4. Known or suspected structural renal abnormality
5. Evidence of sepsis and/or meningitis (appear unwell, shock, hypotension, altered mental state, bulging fontanelle, lumbar puncture suggestive of bacterial meningitis)
6. Received vaccination within 48 hours of attendance
7. Sodium < 128mmol/l on lab or blood gas sample
8. Potassium > 6.5 mmol/l on lab or blood gas sample
9. Plasma creatinine > 50 micromol/l
10. Inability to tolerate oral medication
11. Urine sample was not sent for culture
12. Received additional antibiotics (with the exception of the parenteral antibiotic administered during initial emergency care)
13. Declined consent for participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 30/04/2024: <br><br>Treatment failure (i.e. additional parenteral antibiotics) within seven days of randomisation.<br><br>_____<br><br>Previous primary outcome measure:<br><br>Additional parenteral antibiotics measured using data obtained from medical notes within seven days of randomisation
- Secondary Outcome Measures
Name Time Method