CURLY
Research type
Research Study
Full title
Cefalexin for UTIs – Right treatment Length in Young children (the CURLY trial). A multi-centre, randomised trial to determine the optimal duration of cefalexin therapy for the treatment of febrile urinary tract infections in children.
IRAS ID
1007455
Contact name
Stuart Hartshorn
Contact email
Sponsor organisation
University of Birmingham
Research summary
Urine infections are very common in children. They can cause fever, abdominal pain and vomiting, and are usually treated with antibiotics. In adults, just a few days of antibiotics is usually enough to stop the infection. However, it is unclear if this is the same for children. Shorter treatment with antibiotics has benefits over longer treatments, including less side effects (e.g. diarrhoea, vomiting and rash) and a lower chance of developing bugs resistant to antibiotics (i.e. bacteria that antibiotics can’t kill).
The CURLY trial aims to improve the treatment of children who have urine infections by finding out the shortest course of antibiotics which is effective to successfully cure the infection. The antibiotic used will be cefalexin, which is the most commonly used antibiotic used to treat this type of infection.
The study will be conducted in at least 8 UK emergency departments and will last for a total of 30 months. Around 705 children (aged between 3 months and 11 years) will take part. The amount of antibiotics that children get will be either a 3, 5, 6, 8, or 10 day course. The amount of antibiotics that each child receives will be chosen fairly, using a study process called ‘randomisation’, where each child has an equal chance of getting one of the different courses.
After being discharged home from the emergency department, parents will use a smartphone or computer app to log antibiotic doses and report their child’s symptoms. A follow-up appointment after 16-days will assess the child’s symptoms and check that the infection has cleared from the urine. A further urine sample will be tested after 30 days to check that the infection hasn’t come back. More antibiotics will be prescribed if the treatment is not working well.
At the end of the study, we will know how many days of antibiotics children with urine infections and fever should take to get better.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0275
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion