Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A three part randomized, double-blind, placebo-controlled, parallel group SAD and MD clinical study to evaluate the safety, tolerability and preliminary efficacy of an inhaled (nebulized) phage cocktail in healthy subjects and in patients with chronic colonization of the lung with Pseudomonas aeruginosa

This research is looking into a new inhaled treatment for a common lung infection. The infection is caused by a type of bacteria called Pseudomonas aeruginosa, which can be a problem for people with long-term lung conditions. This early-stage study (Phase I) has two main goals: first, to check if the new inhaled medication is safe for people to use, and second, to see how well the body tolerates it. We also want to get an early idea of whether it could help clear the infection. Both healthy people and patients who have this ongoing lung infection are invited to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Charite Research Organisation GmbH

Enrolment target

Start

08 Aug 2023

Pseudomonas colonization

What is this study about?

This study is designed to explore a new way to treat lung infections caused by a specific type of bacteria called Pseudomonas aeruginosa. These bacteria can be particularly stubborn and difficult to get rid of, especially in people with long-term lung conditions like cystic fibrosis or bronchiectasis.

Researchers are testing a new medicine that you breathe in as a fine mist (called a nebulizer). This medication contains something called 'phages' – these are tiny viruses that naturally target and kill specific bacteria, like Pseudomonas, without harming human cells. The hope is that this phage cocktail could offer a new and effective treatment option.

Because this is a very early study (Phase I), the main focus is on safety. We need to make sure the inhaled treatment doesn't cause any unwanted side effects and that people can tolerate it well. We will also be looking for early signs of whether it helps to reduce the amount of Pseudomonas bacteria in the lungs. By including both healthy volunteers and patients with the infection, we can carefully observe how the treatment behaves in different people.

Key takeaways

This is an early study (Phase I) checking safety and early effectiveness of a new inhaled treatment.
It targets a stubborn lung bacteria called Pseudomonas aeruginosa.
The treatment uses 'phages', viruses that kill bacteria.
Both healthy adults and patients with the infection can take part.
Participation involves using an inhaler and attending clinic visits.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. The study is looking for two groups of people: healthy volunteers, and people who have an ongoing lung infection with the Pseudomonas aeruginosa bacteria.

More detailed checks will happen if you express an interest. For example, the study team will need to make sure your overall health is suitable for the study medicine and for taking part in the research. These checks help ensure your safety throughout the study.

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?
Are you male or female?
Do you currently have a chronic lung infection with Pseudomonas aeruginosa (if applying as a patient)?
Are you generally healthy (if applying as a healthy volunteer)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to one of several groups. Some groups will receive the new inhaled medication, while others might receive a placebo (a dummy treatment with no active medicine) to help compare the effects. You wouldn't know which you received, nor would the doctors, until the study is over.

The study involves regular visits to a clinic for assessments. These will likely include breathing tests, blood samples, and samples from your lungs (like sputum) to check for the bacteria and see how the medication is affecting your body. You'll be asked to use the inhaled medication at home for a period, following specific instructions. The total length of your participation, including follow-up appointments, will be explained in full detail if you are interested.

Potential risks and benefits

Participating in a study like this could potentially offer benefits, such as contributing to new medical knowledge that might help others in the future, and you might receive close medical monitoring. However, there are also potential risks, including side effects from the new inhaled medication, which are currently unknown and why this study is being conducted. There's also a chance you might receive a placebo and not the active drug. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is Pseudomonas aeruginosa?

It's a common type of bacteria that can cause infections, especially in people with lung conditions. It can be hard to treat with usual antibiotics.

What are 'phages'?

Phages are tiny viruses that naturally hunt and kill specific bacteria. Scientists are using them to create new treatments for bacterial infections.

Will I know if I'm getting the real medicine or a dummy treatment?

No, neither you nor your study doctor will know if you're getting the active medication or the placebo until the study is finished. This helps make the study results accurate.

Is this a new type of treatment?

Yes, using phages in this way for lung infections is part of new research. This study is an early step to see if it's safe and effective.

Who is paying for this study?

Typically, clinical trials are funded by pharmaceutical companies, government health organisations, or charities. The study team will provide you with this information.