Enhancing Lung Health in Kids with structural Lung Damage and Malformations: a randomized controlled trial on Azithromycin (AZI) for Airway Infection Prevention
This study is investigating if a common antibiotic, azithromycin, can reduce chest infections in children who have ongoing lung problems or unusual lung development. These conditions can make children more likely to get breathing issues. Researchers want to see if giving azithromycin regularly can help prevent these illnesses. We will be comparing children who receive azithromycin with children who receive a placebo (a dummy medicine with no active drug) to find out if the antibiotic makes a real difference. The main goal is to count how many chest infections each group has over a specific period.
At a glance
What is this study about?
This study, called "Enhancing Lung Health in Kids," is looking into how we can better support children who have ongoing problems with their lungs, either because of how their lungs developed or because of damage. Conditions like chronic atelectasis, cystic lung malformations, or bronchiectasis mean that parts of a child's lungs might not work as well as they should, or they might have an unusual shape. This can unfortunately lead to them getting chest infections more often.
The research is focusing on a medicine called azithromycin, which is an antibiotic. Antibiotics are medicines used to treat and sometimes prevent bacterial infections. In this study, we want to find out if giving azithromycin regularly can help stop these children from getting so many chest infections. By preventing these infections, we hope to improve their overall health and reduce the need for hospital visits.
To do this, some children will receive azithromycin, while others will receive a placebo, which looks exactly like the medicine but contains no active drug. This is a common way to test medicines fairly, as it helps us see if any improvements are truly due to the medicine or to other factors. We’ll be carefully comparing the number of chest infections in both groups to understand if azithromycin is an effective treatment for preventing these problems.
Key takeaways
- This study is testing if azithromycin can prevent chest infections in children with certain lung problems.
- Children will receive either azithromycin or a placebo (dummy medicine).
- The main goal is to count how many chest infections children have in each group.
- Participation involves taking regular medicine and having routine check-ups.
- There are potential benefits and risks, which will be fully explained.
Who may be eligible?
This study welcomes children of all ages and genders who have specific lung conditions. These conditions include various issues where the lungs haven't developed typically or have experienced some damage, making children more prone to chest infections. Examples include conditions where parts of the lung might be collapsed, misshapen, or weakened.
Because this is an advanced study (a Phase 4 clinical trial), it means the medicine, azithromycin, is already a known treatment for other conditions. However, we're now testing if it can specifically help children with these particular lung problems.
If your child has one of the listed lung conditions, like chronic atelectasis, bronchiectasis, or certain types of lung malformations, and you are interested in them possibly taking part, the study team would be able to give you more detailed information on whether your child fits all the specific requirements.
- Does your child have a diagnosed structural lung condition or malformation?
- Does your child get frequent chest infections?
- Is your child currently receiving care for their lung condition?
- Are you comfortable with your child potentially receiving a placebo?
- Are you able to attend regular appointments for your child?
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 will either receive the study medicine, azithromycin, or a placebo (a dummy medicine). Both the medicine and the placebo will be given as a liquid. You won't know which one your child is receiving, and neither will the study team, to make sure the results are fair. Your child will need to take this medicine regularly for a certain period, and you'll be given clear instructions on how and when to give it.
During the study period, the research team will keep a close eye on your child's health. This will involve regular check-ups, which might be at a clinic or sometimes over the phone. These check-ups will help us record how many chest infections your child experiences, how long they last, and if they need to go to the hospital. All these appointments and assessments will be explained to you in detail before you decide to join.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is azithromycin?
Azithromycin is a type of medicine called an antibiotic, used to fight bacterial infections.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps us fairly test the medicine.
Will my child automatically receive the medicine?
No, your child will be randomly assigned to either receive the study medicine (azithromycin) or the placebo.
What does a 'chest infection' mean in this study?
In this study, a chest infection refers to a worsening of your child's breathing problems that needs medical attention, such as antibiotics or hospital care.
How long will my child be in the study?
The study team will explain the exact duration, but it will involve taking the medicine for a specific period and having follow-up check-ups.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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