RecruitingRare disease

A study on azithromycin for preventing airway infections in children aged 0-72 months with structural lung damage or congenital lung and airway malformations

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves children with several different lung conditions including tracheomalacia, cystic lung malformations, problems after vascular ring with central airway compression, lobar hyperinflation syndrome, bronchopulmonary dysplasia, bronchiectasis, and chronic atelectasis. These conditions involve structural damage to the lungs or airways that a child was born with or developed early in life, which can make it easier for infections to occur. The treatment being tested is azithromycin, which is an antibiotic that may help prevent lung infections when given regularly over time. Some children in the study will receive azithromycin while others will receive placebo.

The purpose of the study is to find out if giving azithromycin for six months can reduce the number of times children with these lung problems experience respiratory infections that get worse and need treatment. During the study, children will receive either azithromycin or placebo by mouth for a period of six months. The medicine comes as a liquid suspension that can be swallowed. Researchers will track how many times the children develop breathing problems that get worse during the treatment period, which are called respiratory exacerbations.

The study will also look at other important information such as how long these episodes of worsening breathing problems last, how many times children need to be admitted to the hospital, and how long those hospital stays are. Children participating in the study will be between zero and seventy-two months of age, which means from newborns up to six years old. All participating children will already be receiving care at specialized pediatric lung centers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment assignment
Upon joining the study, you will be assigned to receive either azithromycin or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.
The assignment will be random, meaning it will be determined by chance, similar to flipping a coin. Neither you nor the medical staff will know which treatment your child receives during the study.
Step 2
Medication administration
Your child will receive either azithromycin oral suspension or placebo for azithromycin.
The medication is given by mouth as a liquid suspension.
The treatment will continue for 6 months.
You will need to administer the medication to your child according to the instructions provided by the study staff.
Step 3
Monitoring of respiratory symptoms
Throughout the 6-month treatment period, you will need to monitor your child for any respiratory exacerbations. These are episodes when breathing problems or lung symptoms become worse.
You will be asked to record information about any breathing difficulties, infections, or worsening of lung symptoms that occur during the study.
Step 4
Recording of antibiotic use
If your child develops a respiratory infection that requires treatment with antibiotics during the study period, this information will need to be documented.
You will be asked to keep track of when these infections occur and how long they last.
Step 5
Recording of hospital admissions
If your child needs to be admitted to the hospital for breathing problems or lung-related issues during the 6-month treatment period, this information will be recorded.
Details about the length of hospital stays will also be documented.
Step 6
Completion of treatment period
The treatment phase will end after 6 months of receiving the assigned medication.
All information collected during this period will be used to compare the effects of azithromycin versus placebo on respiratory health.

Who can join the trial?

5 criteria

The child must have structural lung damage (permanent changes to the lung tissue) or congenital lung and airway malformations (problems with the lungs or breathing tubes that the child was born with), confirmed by imaging tests like X-rays or CT scans, or by bronchoscopy (a procedure where a small camera is used to look inside the airways).
The child must be receiving regular care at one of the three specialized children's lung clinics in Denmark.
The child must be at risk of getting breathing infections that need antibiotics (medicines that fight bacterial infections), or must have already had breathing infections that required antibiotics.
The child must be between 0 and 72 months old (from birth up to 6 years of age).
The parents must provide written permission for their child to take part in the study, following local rules and regulations.

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified for this clinical trial in the provided information.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Odense University Hospital
Odense, Denmark
Verified
Rigshospitalet
Copenhagen, Denmark

Trial locations

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Investigated drugs

Azithromycin is an antibiotic medication that helps fight bacterial infections. In this trial, it is being tested to see if it can prevent airway infections in young children who have structural lung damage or were born with lung and airway malformations. The medication is given as a maintenance treatment over 6 months to help reduce breathing problems and respiratory flare-ups in these children.

Azithromycin

What is already known about the treatment

Azithromycin – Azithromycin is an antibiotic medication that is typically given by mouth as tablets, liquid suspension, or sometimes through an intravenous injection into a vein. It is widely used in medicine to treat various bacterial infections and has been studied for preventing repeated lung infections in children with lung structure problems. The medication works by stopping bacteria from making proteins they need to survive and grow, which helps prevent and control infections in the airways. In this clinical trial, it is being tested as a preventive treatment given regularly over six months to reduce breathing problems and lung infections in infants and young children who have damaged lungs or were born with lung abnormalities.

Investigated diseases

Tracheomalacia
A condition where the walls of the windpipe are weak and floppy instead of being firm and rigid. This weakness causes the airway to narrow or collapse, especially during breathing, coughing, or crying. The condition can make breathing difficult and cause a harsh, vibrating sound when air moves through the affected area. It may be present from birth or develop later due to other factors. Symptoms often include noisy breathing, frequent coughing, and difficulty clearing mucus from the airways. The condition can affect infants and young children as their airways continue to develop.
Cystic Lung Malformations
A group of abnormal developments in the lungs that occur before birth, where parts of the lung tissue do not form properly. These malformations create abnormal air-filled spaces or cysts within the lung tissue. The affected areas of the lung do not function normally and cannot properly exchange oxygen and carbon dioxide. Some children may have breathing difficulties, while others may experience repeated lung infections in the affected areas. The size and location of the malformation determine how much it affects breathing and lung function. These abnormalities are present from birth and remain throughout life.
Post-Vascular Ring with Central Airway Compression
A condition that occurs after the presence of abnormal blood vessel formations around the windpipe and food pipe, which squeeze and narrow the breathing passages. The compression of the airway makes it difficult for air to flow freely through the windpipe. Children with this condition may experience noisy breathing, difficulty breathing, and frequent respiratory infections. The pressure on the airway can cause ongoing breathing problems even after the vascular ring itself has been addressed. The narrowed airway is more prone to inflammation and swelling. Symptoms may vary depending on how much the airway remains compressed.
Lobar Hyperinflation Syndrome
A condition where one section of the lung becomes overinflated with air that cannot escape properly. The affected lobe traps air inside and expands beyond its normal size, potentially compressing nearby healthy lung tissue. This overinflation prevents the affected part of the lung from working properly and can interfere with the function of surrounding lung areas. Breathing may become difficult as the overinflated lobe takes up space needed for normal lung expansion. The condition can cause rapid breathing, wheezing, and reduced oxygen levels in the blood. It typically affects infants and young children during their early development.
Bronchopulmonary Dysplasia
A chronic lung condition that develops in premature babies who have received breathing support with oxygen and mechanical ventilation. The lungs of affected infants are underdeveloped and become damaged from the treatments needed to help them breathe. This damage causes scarring and inflammation in the small airways and air sacs of the lungs. Babies with this condition need extra oxygen for weeks or months and may have difficulty breathing. The lungs grow and heal slowly over time, but the airways remain sensitive and prone to infections. Children may experience wheezing, rapid breathing, and increased effort to breathe during their early years.
Bronchiectasis
A condition where the airways in the lungs become permanently widened and damaged, losing their normal shape and elasticity. The damaged airways cannot clear mucus effectively, allowing it to build up and create an environment where bacteria can grow. This leads to repeated infections that cause further damage to the airway walls. The cycle of infection and inflammation continues to worsen the condition over time. Children with bronchiectasis have a persistent cough that produces mucus and experience frequent chest infections. The damaged airways become scarred and thickened, making breathing less efficient.