A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
This study is about a lung infection called Mycobacterium avium complex pulmonary disease (MAC-PD). We want to understand how a standard three-drug treatment works for patients during the first six months. Researchers will look at how effective the treatment is, if people are able to take their medicines as prescribed, and if their doctors need to make changes to their treatment plan. At the moment, treatments for MAC-PD don't always work as well as we'd like, and side effects or difficulty sticking to the treatment can be common. This study aims to gather important information from many hospitals to help doctors improve future care and treatment for people with MAC-PD. It will help us learn more about this condition and how best to manage it.
At a glance
What is this study about?
This study is gathering information about a lung infection called Mycobacterium avium complex pulmonary disease, or MAC-PD. This infection is caused by a type of germ found in the environment. While most people don't get sick from these germs, some develop a lung infection that can be difficult to treat.
Currently, about half to 70% of people get better with the usual treatment, which involves taking three different medicines. However, side effects from these medicines and the challenge of taking them regularly can sometimes make it hard for people to complete their treatment successfully. We don't have enough clear information from studies about how well these treatments truly work in real life, how often people stick to their treatment, or why doctors might need to change the medicines over time.
To fill this gap, doctors from many hospitals are working together to collect detailed information about patients with MAC-PD. They will follow patients for the first six months of their treatment. By carefully observing what happens to many people, this study aims to provide a much clearer picture of the best ways to treat MAC-PD. This knowledge will help improve treatment success and make it easier for people with this condition to get better in the future.
Key takeaways
- This study observes standard MAC-PD lung infection treatment.
- It aims to understand treatment effectiveness and adherence.
- Information is collected during routine doctor visits for 6 months.
- You will receive the usual anti-infective medications.
- The goal is to improve future care for people with MAC-PD.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and have recently been diagnosed with MAC-PD, or have had it before and it has come back. Your doctor must have decided that you need to start the standard three-drug antibiotic treatment for this condition. You also need to fully understand the study and agree to take part by signing a consent form.
There are several reasons why someone might not be able to join. For example, if you are very unwell, have certain other serious health conditions like HIV or cystic fibrosis, or have other active infections like tuberculosis. If you've been on antibiotics for your current MAC infection for more than a month already, or if your previous MAC-PD treatment was less than six months ago, you won't be able to join.
Also, if you have a serious medical condition such as certain cancers that require treatment, or if you have known issues with drug or alcohol use that your doctor believes would make it unsafe for you to participate, you would not be eligible for this 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?
- Have you recently been diagnosed with MAC-PD (or is it a recurrence)?
- Are you about to start a three-drug treatment for MAC-PD?
- Do you not have conditions like HIV, cystic fibrosis, or active cancer requiring treatment?
- Have you not had more than one month of treatment for this current MAC infection?
- Have you signed a form saying you understand and agree to take part?
What does participation involve?
This study will mainly involve doctors collecting information about your MAC-PD treatment and progress during your regular doctor visits over the first six months. You won't be given any new or experimental drugs as part of this study; you'll be receiving the standard three-drug antimycobacterial therapy recommended by treatment guidelines. The researchers will simply observe how this treatment works for you.
Researchers will record details about the medicines you take, how well you stick to your treatment plan, and any adjustments your doctor makes to your medication. They will also note any side effects you experience and how your infection responds to the treatment. This information will be gathered during your routine appointments, so there won't be any extra visits specifically for the study. The total duration of active observation for each patient in the study will be six months.
Potential risks and benefits
Locations (11)
- Oregon Science and Health UniversityVerified postcodePortland, United States· Recruiting
- UZ LeuvenVerified postcodeLeuven, Belgium· Recruiting
- University of CalgaryVerified postcodeCalgary, Canada· Recruiting
- University Hospital Center ZagrebVerified postcodeZagreb, Croatia· Recruiting
- Aarhus University HospitalVerified postcodeAarhus, Denmark· Recruiting
- Rasmus Rude LaubVerified postcodeHellerup, Denmark· Recruiting
- University Hospital FrankfurtVerified postcodeFrankfurt, Germany· Recruiting
- Fukujuji HospitalVerified postcodeTokyo, Japan· Recruiting
- Radboud University Medical CenterVerified postcodeNijmegen, Netherlands· Recruiting
- Seoul National University HospitalVerified postcodeSeoul, South Korea· Recruiting
- Hospital Clínic de BarcelonaVerified postcodeBarcelona, Spain· Recruiting
Common questions
What is MAC-PD?
MAC-PD is a lung infection caused by a common type of germ called Mycobacterium avium complex that can sometimes make people unwell.
Will I get new medicine in this study?
No, you will receive the standard three-drug treatment that your doctor would normally prescribe for MAC-PD. The study is just observing how well this treatment works.
How long will I be in the study?
The study will collect information about your treatment and progress for the first six months of your MAC-PD therapy.
Do I have to go to extra appointments for the study?
No, information will be gathered during your regular doctor's visits for your MAC-PD treatment.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it will not affect your medical care.
How to find out more
Arthur Lemson, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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