PYELOCOURT - 3-day intravenous antibiotic treatment versus 3-day intravenous followed by 7-day oral antibiotic treatment for acute pyelonephritis in children 1 month to 3 years old: a non-inferiority open randomized multicentric clinical trial
This study, called PYELOCOURT, is for young children, specifically those aged 1 month to 3 years, who have a kidney infection (acute pyelonephritis). Researchers want to find the best way to treat these infections using antibiotics. There are two treatment groups: one receives antibiotics through a drip (IV) for 3 days, and the other receives antibiotics through a drip for 3 days, followed by 7 days of antibiotics taken by mouth. The main question the study hopes to answer is whether the shorter, all-IV treatment works just as well as the longer combined treatment in preventing the infection from returning within about a month after treatment finishes. This is a Phase III trial, meaning it's a key step to confirm how well these treatments work in a larger group of patients.
At a glance
What is this study about?
This study, called "PYELOCOURT", is looking into the best way to treat a specific type of kidney infection in very young children, from one month old up to three years old. This infection is called acute pyelonephritis, and it can make children quite unwell.
The researchers want to compare two different ways of giving antibiotics. One group of children will have antibiotics given through a drip (intravenously, or IV) for 3 days. The other group will first have antibiotics through a drip for 3 days, and then switch to antibiotics taken by mouth (orally) for another 7 days. The main goal is to see if the shorter IV-only treatment is just as good as the longer combined treatment at stopping the infection from coming back. This type of research helps doctors understand which treatments are most effective and convenient for children and their families.
This is a 'Phase III' study, which means it's a detailed investigation to confirm the effectiveness and safety of these treatment approaches. The results will help doctors make better decisions about how to treat these kidney infections in the future.
Key takeaways
- Clinical trial for children aged 1 month to 3 years with kidney infections.
- Compares two antibiotic treatments: 3-day IV vs. 3-day IV + 7-day oral.
- Main goal: prevent infection from returning after treatment.
- Participation involves medical visits, tests, and follow-up over several months.
- Aims to improve future treatment guidelines for kidney infections in children.
Who may be eligible?
This study is particularly for young children who have been diagnosed with a kidney infection, specifically what doctors call 'acute pyelonephritis'.
Children aged between 1 month and 3 years old can take part. Both boys and girls are welcome to join the study if they meet the other requirements. The study will likely involve tests to confirm the kidney infection and make sure the child is suitable for the study treatments.
More specific details about which children can or cannot join will be discussed by the study team. For example, they will check if your child has other health conditions that might make participation unsuitable.
- Is my child between 1 month and 3 years old?
- Does my child have a diagnosed kidney infection (acute pyelonephritis)?
- Is my child able to attend regular hospital or clinic appointments?
- Does my child have any other serious health conditions that might prevent participation? (Discuss with doctor)
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your child takes part in this study, they would be randomly assigned to one of two treatment groups. One group will receive antibiotics through a drip for 3 days. The other group will receive antibiotics through a drip for 3 days, followed by 7 days of antibiotics taken by mouth. You won't be able to choose which group your child is in; it will be decided by chance, like flipping a coin.
Your child will have a number of visits to the clinic or hospital, and some follow-up phone calls. These visits will check how your child is recovering, look for any signs of the infection returning, and monitor for any side effects from the medication. There will also be some tests, such as urine samples, to see if the infection is clearing up and to check for any changes in gut bacteria. The initial treatment phase will last for up to 10 days (3 days IV plus 7 days oral for one group, or just 3 days IV for the other), but the full follow-up for the study will last for a few months, with key checks at about one month and three months after starting treatment. The total duration of your child's involvement in the study, including all follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is acute pyelonephritis?
It's a serious type of kidney infection that can make children very ill. It needs prompt treatment with antibiotics.
What does 'IV' mean?
IV stands for 'intravenous', which means the medicine is given directly into a vein, usually through a drip.
Will my child automatically get better if they join the study?
The study aims to find the most effective treatment, but like any medical treatment, there's no guarantee. Your child will receive standard care and close monitoring.
What are the antibiotics being used?
The study is looking at treatments involving antibiotics like Cefixime, Ceftriaxone, Amikacin, and a combination of Sulfamethoxazole and Trimethoprim.
What happens if the infection comes back?
The study will carefully monitor for the infection returning. If it does, your child will receive appropriate medical care as per their doctor's guidance.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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