Active not recruitingPHASE2INTERVENTIONAL

Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options

We are looking into a new medication called rezafungin for adults aged 18 and over who have a lung condition called Chronic Pulmonary Aspergillosis (CPA). This is a fungal infection that can cause serious damage to the lungs. This trial is specifically for people whose current treatments aren't working well or who can't take other common medications for CPA. The main goal is to find out if taking rezafungin once a week for six months is both safe and effective. We will be checking how well it helps control the infection, improves breathing, and generally makes people feel better, using scans, questionnaires, and regular check-ups.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Mundipharma Research Limited

Enrolment target

Start

30 Jun 2025

Estimated completion

30 Dec 2026

Chronic Pulmonary Aspergillosis

What is this study about?

Chronic Pulmonary Aspergillosis (CPA) is a long-term fungal infection that mainly affects the lungs. It can slowly cause damage, leading to symptoms like a persistent cough, shortness of breath, weight loss, and feeling generally unwell. While there are treatments available, particularly a group of medicines called azoles, these don't work for everyone. Some people find that azoles aren't effective, often because the fungus can become resistant to them, or they might experience side effects that prevent them from continuing treatment. When these standard treatments aren't an option, patients have very few alternatives, and these often involve daily hospital visits for IV medication, which isn't practical long-term.

This is where the new study comes in. We are exploring a new drug called rezafungin. It's hoped that this medication could offer a new and effective way to treat CPA, especially for those who have exhausted other options. The trial aims to collect information on how well rezafungin works and if it's safe for people with CPA by giving it once a week for six months.

If successful, this research could provide a much-needed treatment choice for people living with CPA, improving their health and quality of life. It’s important to find new treatments as CPA can have a significant impact on someone's life and sometimes lead to serious complications if not managed effectively.

Key takeaways

Tests a new weekly drug (rezafungin) for CPA.
For adults (18+) with CPA who have limited treatment options.
Aims to check if rezafungin is safe and effective over six months.
Involves monthly clinic visits for checks, tests, and questionnaires.
Could offer a new option if standard treatments aren't suitable.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult men and women, aged 18 or older, who have been diagnosed with Chronic Pulmonary Aspergillosis (CPA) for at least three months. To be part of the trial, your doctor will need to confirm your CPA diagnosis based on specific symptoms, lung scans (CT scans), and tests that show evidence of an Aspergillus infection, like blood tests or samples from your lungs.

A key part of joining this study is that you must be unable to take standard antifungal medications called azoles. This could be because they haven't worked for you, you can't tolerate them due to side effects, they interact badly with other medicines you take, or you can't take medicines by mouth. You also can't have certain other active lung infections, like active tuberculosis, that might make it hard to see if the new drug is working.

If your doctor believes your CPA is getting worse (shown on scans) or you have a lot of symptoms, and you meet these other conditions, then you might be a good fit for this study. Women who can still have children will need to agree to use effective birth control methods during the study.

Quick self-check

I am 18 years old or older.
I have been diagnosed with Chronic Pulmonary Aspergillosis (CPA) for at least 3 months.
My doctor has confirmed I cannot take standard azole antifungal medicines.
My doctors think my CPA is getting worse or I have significant symptoms.
I do not have active tuberculosis or certain other active lung infections.

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

What does participation involve?

If you decide to take part in this study, you will receive the study medication, rezafungin, once a week for six months. This will involve regular visits to the clinic, typically once a month, for check-ups and various tests. These tests may include blood samples, physical examinations, and possibly more lung scans (CT scans) to monitor your condition and see how the medication is working.

You will also be asked to complete questionnaires about your health, how you are feeling, and your overall wellbeing. These questionnaires help us understand the impact of the treatment on your daily life. The entire study participation, including the treatment and follow-up assessments, will last for about six months.

It's important to remember that throughout the study, you will have regular contact with the study team who can answer any questions and address any concerns you might have. You are free to withdraw from the study at any time.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving a new treatment, rezafungin, for your CPA, especially if other treatments haven't worked or aren't suitable for you. This could potentially improve your symptoms and lung health. However, like all medications, rezafungin may have side effects, and some are not yet known. The study team will closely monitor you for any potential risks or side effects. You will be given full information about known risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (37)

Kepler University Hospital
Linz, Austria
Brussels University Hospital
Brussels, Belgium
UZ Gent
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
CHU UCL Namur
Yvoir, Belgium
CHU Amiens Picardie
Amiens, France
Institut Coeur Poumon CHU
Lille, France
CHU Arnaud de Villeneuve
Montpellier, France
CHU Bordeaux
Pessac, France
Evangelische Lungenklinik Berlin
Berlin, Germany
University of Cologne
Cologne, Germany
Asklepios Lungenfachklinik Gauting
Gauting, Germany

+25 more sites — see the official record for the full list.

Common questions

What is Chronic Pulmonary Aspergillosis (CPA)?

CPA is a serious, long-term fungal infection that typically affects the lungs and can cause damage over time.

What is rezafungin?

Rezafungin is a new drug being tested as a weekly treatment for CPA, particularly for people who can't use other existing medications.

How long will I be in the study?

If you join, you will receive the study drug for six months and have regular check-ups during that time.

Do I have to stop my current CPA medication?

Yes, this study is for individuals who cannot take standard azole antifungal therapy. You cannot be on azoles during the study.

What if I get worse during the study?

Your health will be closely monitored by the study team, and you can withdraw from the study at any time if you feel unwell or for any other reason.