Urinary tract infection (UTI) Infections and Infestations
Conditions
Interventions
This study investigates oral antibiotics and the continuation of oral treatment at least until urine culture results are known (typically after 36 to 48 hours).
Randomisation:
Participants will be ra
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Age
29 Days to 90 Days
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 18/12/2024: 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 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) _____ Previous participant inclusion criteria as of 30/04/2024 to 18/12/2024: 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 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* assessed by a consultant grade doctor. _____ Previous participant 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 500 and <5200/mm3
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 18/12/2024: 1. Born at 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 participant exclusion criteria: 1. Born at 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 30/04/2024: Treatment failure (i.e. additional parenteral antibiotics) within seven days of randomisation. _____ Previous primary outcome measure: Additional parenteral antibiotics measured using data obtained from medical notes within seven days of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/04/2024: The following secondary outcome measures are assessed up to 28 days after randomisation unless otherwise stated: 1. Treatment failure (i.e. additional parenteral antibiotics) assessed at day 28 2. Escalation in care defined as, escalation in the level of care (i.e. admission from home, admission to intensive care or a high dependency unit) OR change in antibiotic therapy OR death due to poor response. Assessed at 7 and 28 days. 3. Time to defervescence 4. Time to normal feeding (as reported by parent/guardian) 5. Time to normal activity (as reported by parent/guardian) 6. Length of stay 7. Antibiotic-associated adverse events (including diarrhoea and allergic reaction) 8. Antibiotic adherence (full course taken or no more than two missed doses) 9. Paediatric quality of life (measured using PedsQL acute infant version) within 24 hours of randomisation, day 7 and day 28 10. Family impact (measured using PedsQL Family Impact Module acute version) at day 7 11. Health service use and costs _____ Previous secondary outcome measures: The following secondary outcome measures are assessed up to 28 days after randomisation unless otherwise stated: 1. Treatment failure defined as, escalation in the level of care i.e. admission from home, admission to intensive care or a high dependency unit OR change in antibiotic therapy due to poor response OR Death measured using data obtained from medical notes at 7 and 28 days 2. Treatment failure in those children with a confirmed UTI measured using data obtained from medical notes within 28 days of randomisation 3. Time to defervescence measured using data obtained from medical notes 4. Time to normal feeding (as reported by parent/guardian) 5. Time to normal activity (as reported by parent/guardian) 6. Length of hospital stay measured using data obtained from medical notes 7. Antibiotic-associated adverse events (including diarrhoea and allergic reaction) measured using data o | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactStudy Team
Outcome results
None listed