Randomized, double-blind, parallel-group clinical trial, compared with placebo to evaluate the efficacy and safety of three antibiotic treatment regimens for the eradication of primary P. aeruginosa infection in patients with bronchiectasis
This research study is for people in the UK who have bronchiectasis and also have a lung infection caused by a germ called P. aeruginosa. We are testing different antibiotic treatments to see how well they clear up this infection and whether they are safe. Some people will receive antibiotics, while others will get a placebo (a dummy treatment). We will be checking if the infection goes away by looking at sputum samples (phlegm) or samples from inside the lungs. We'll also be looking at how often people get sick, their quality of life, and any side effects. Our goal is to find better ways to treat this specific lung infection in people with bronchiectasis.
At a glance
What is this study about?
You've been invited to learn about a research study for people who have bronchiectasis. Bronchiectasis is a long-term condition where your airways become widened and scarred, making it harder to clear mucus. This can lead to frequent lung infections.
Sometimes, these infections are caused by a specific germ called *P. aeruginosa*. This study is designed to find the best way to treat this particular infection in people with bronchiectasis. We want to see if certain antibiotics are more effective and safer at getting rid of the germ compared to no active treatment (a placebo).
The study will look closely at whether the infection is cleared from your lungs and if it stays away. We will also monitor how you feel, how often you get chest infections, and your overall quality of life. The information we gather will help doctors understand which treatments work best for people like you with this type of lung infection.
Key takeaways
- This study evaluates new antibiotic treatments for *P. aeruginosa* lung infections in bronchiectasis.
- It compares active treatments with a placebo (dummy treatment).
- Participation involves regular hospital visits, taking medication, and providing samples.
- The aim is to find safer and more effective ways to clear lung infections.
- Your quality of life and any side effects will be carefully monitored.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
This study is looking for adults aged 18 or over. Both men and women can take part.
To be considered for this study, you must have a diagnosis of bronchiectasis and also have an active lung infection caused by the *P. aeruginosa* germ. The study team will check your medical records and perform some tests to make sure you meet all the specific requirements.
There might be other health conditions or medications that would prevent you from taking part, but the study team will discuss all of these with you in detail.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of bronchiectasis?
- Has a recent test confirmed you have a *P. aeruginosa* lung infection?
- Are you based in the UK and able to attend study appointments?
What does participation involve?
If you decide to join this study, you will be given one of the study treatments for a set period. Some treatments are taken by breathing them in using a nebuliser, and others are tablets or given directly into a vein. For a short time, you might also be given a dummy treatment (placebo) instead of an active medicine to help us compare the results.
You will need to attend several appointments over a period of time, where the study team will take samples, such as sputum (phlegm), to check for the *P. aeruginosa* germ. They will also ask you about your symptoms, how you are feeling, any side effects you might be having, and ask you to complete questionnaires about your quality of life. We will also be checking your health regularly. The total duration of your participation, including follow-up, will be decided by the study design, and the team will explain this fully.
Potential risks and benefits
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Common questions
What is *P. aeruginosa*?
*P. aeruginosa* is a common type of germ that can cause lung infections in people with conditions like bronchiectasis.
What is a placebo?
A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the true effects of the study drug.
How will you know if the treatment works?
We will check samples of your phlegm (sputum) or from your lungs to see if the *P. aeruginosa* germ has gone away after treatment.
Will I know which treatment I'm getting?
Neither you nor your study doctor will know which treatment you are receiving (active drug or placebo) during the study. This helps ensure fair results.
How long will I be involved in the study?
More detailed information about the length of your participation will be provided by the study team, but it will involve several follow-up visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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