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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Study
Team
-
easystudy@nictu.hscni.net
Dr
Thomas
Waterfield
+44 (0)7872990521
t.waterfield@qub.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Urinary tract infection (UTI)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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 the hospital for a minimum of 36 to 48 hours to wait for the 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 for 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 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 EASY study aims 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant exclusion criteria as of 18/12/2024: 1. Born at <30 weeks gestation 2. Discharged from hospital more than 7 days after birth 3. History of re-admission to hospital that required treatment with parenteral antibiotics 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
_____
Previous participant exclusion criteria as of 30/04/2024 to 18/12/2024: 1. Born at <30 weeks gestation2. Discharged from hospital more than 7 days after birth3. Required re-admission to hospital after birth for more than 24 hours4. Known or suspected structural renal abnormality5. 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 attendance7. Sodium < 128mmol/l on lab or blood gas sample8. Potassium > 6.5 mmol/l on lab sample9. Plasma creatinine > 50 micromol/l10. Inability to tolerate oral medication11. Urine sample was not sent for culture12. 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 <30 weeks gestation2. Discharged from hospital more than 7 days after birth3. Required re-admission to hospital after birth for more than 24 hours4. 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 attendance7. Sodium < 128mmol/l on lab or blood gas sample8. Potassium > 6.5 mmol/l on lab or blood gas sample9. Plasma creatinine > 50 micromol/l10. Inability to tolerate oral medication11. Urine sample was not sent for culture12. Received additional antibiotics (with the exception of the parenteral antibiotic administered during initial emergency care)13. Declined consent for participation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Study
Team
-
easystudy@nictu.hscni.net
Dr
Thomas
Waterfield
+44 (0)7872990521
t.waterfield@qub.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Belfast Health and Social Care Trust and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 61097
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
