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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Adding oxygen to enhance antibiotic treatment of chronic lung infection

This research is investigating whether giving extra oxygen, alongside standard antibiotics, could improve treatment for ongoing lung infections. It's particularly looking at people who have conditions like cystic fibrosis or primary ciliary dyskinesia, where these infections are common and often hard to clear. The study is in its very early stages, called 'Phase I Human Pharmacology'. This means the main goal is to check the safety of giving oxygen with antibiotics and to understand how this combination affects the body. Researchers want to see if this approach could be a new way to make antibiotic treatments more effective for serious lung infections, helping people breathe easier and feel better in the long run.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Rigshospitalet
Enrolment target
10
Start
13 Sep 2024

What is this study about?

This study is about a new idea to help people with long-term lung infections, especially those caused by a germ called Pseudomonas aeruginosa. These infections can be really tough to get rid of, especially for individuals who have conditions like cystic fibrosis or primary ciliary dyskinesia, which affect the lungs.

The researchers are trying to find out if giving people extra oxygen at the same time they are taking their usual antibiotics could make the antibiotics work better. Think of it like this: sometimes, germs can hide in places where there isn't much oxygen, making them harder for antibiotics to reach. The idea is that more oxygen might weaken these germs or help the antibiotics do their job more effectively.

This is a very early-stage study, called 'Phase I'. This means the most important thing the researchers want to learn is whether this combination of oxygen and antibiotics is safe for people. They will also be looking closely at how the body reacts to this treatment. If it proves safe and shows promise, it could pave the way for future studies and potentially a new way to treat persistent lung infections.

Key takeaways

  • Researcher are exploring oxygen to boost antibiotic effect.
  • Aimed at long-term lung infections in conditions like cystic fibrosis.
  • This is an early-stage study focused on safety.
  • Open to adults aged 18 and over, both men and women.
  • Participation involves clinic visits and health monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so older adults can also take part. Both men and women are welcome to participate in this research.

The study is specifically for people who have certain long-term lung conditions. This includes individuals diagnosed with primary ciliary dyskinesia, cystic fibrosis, or those with ongoing lung infections caused by a specific type of germ called Pseudomonas aeruginosa. These are the main conditions the researchers are focusing on.

It's important to remember that this is a very early study. Other specific health details might also be checked by the study team to make sure it's the right fit for you and safe for you to participate.

Quick self-check
  • Are you at least 18 years old?
  • Do you have primary ciliary dyskinesia, cystic fibrosis, or chronic Pseudomonas lung infection?
  • Are you willing to attend regular clinic appointments?
  • Are you comfortable with receiving extra oxygen as part of a treatment?
  • Are you able to understand and sign an informed consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would undergo various assessments, such as breathing tests, blood tests, and possibly scans, to monitor your lung health and how your body is responding. The study would involve receiving extra oxygen as part of the treatment, alongside your prescribed antibiotics. The exact details of how the oxygen is given (e.g., through a mask or nasal tubes) and for how long each day would be explained fully by the study team.

There will be follow-up appointments to check on your progress and health after the main treatment period. The total length of your participation, including all treatments and follow-up visits, would be clearly explained to you before you agree to join. You would not be expected to pay for any study-related treatments or visits.

Potential risks and benefits

While we hope this study could lead to better treatments for lung infections, there's no guarantee you will personally benefit. Benefits might include closer monitoring of your health. Potential risks might involve side effects from the oxygen or antibiotics, or discomfort during tests. The study team will explain all known risks. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Denmark

Common questions

What is Pseudomonas aeruginosa?

It's a common type of bacteria that can cause serious and persistent lung infections, especially in people with weakened lungs.

What does a 'Phase I' study mean?

It's the first stage of human testing, mainly focused on checking if a new treatment or approach is safe and understanding how it works in the body.

Will taking part affect my usual medical care?

No, your decision to join or not join, or to leave the study, will not affect the ongoing care you receive from your doctors.

Will I have to pay to be in the study?

No, you will not have to pay for any of the treatments, tests, or visits that are part of this research study.

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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