Mycobacterium Avium Complex Pulmonary DiseaseMAC-PD cohortNCT05906316
A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
An observational study of Mycobacterium Avium Complex Pulmonary Disease, run by Radboud University Medical Center at 11 sites in 10 countries.
Trial summary
To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium Complex Pulmonary Disease
- How many people
- 100 participants
- Where
- 11 sitesin 10 countries
- Study dates
- 1 Jul 2023to 1 Sep 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Mycobacterium avium complex pulmonary disease that (MAC-PD) requires guideline-based three-drug antimycobacterial therapy. MAC is the most common causative species of pulmonary NTM infections.
Who may be able to join
- Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
- Signed and dated informed consent
Who cannot join
- The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
- The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
- HIV-infection;
- Cystic fibrosis;
- >1 month antibiotic treatment for current MAC infection;
- < 6 months between previous antimycobacterial NTM-PD treatment and antimycobacterial treatment for current MAC-PD
Show all 9Show fewer
- Disseminated MAC infection;
- Active pulmonary tuberculosis, fungal or nocardial disease requiring treatment;
- Active pulmonary malignancy (primary or metastatic) or any other malignancy requiring chemotherapy or radiotherapy within 6 months before screening or anticipated during the study period;
Trial locations and contacts
11 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 10 countries
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Andreas Fløe Hvass, MD, PhD, +45 70 11 31 31, andrniel@rm.dk
- Recruiting
Rasmus Rude Laub
Hellerup
+45 38 67 38 67, rasmus.rude.laub@regionh.dk
United States1 site, 1 recruiting
- Recruiting
Oregon Science and Health University
Portland, Oregon, 97239
Kevin Winthrop, MD, MPH
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Natalie Lorent, MD, PhD, +32 16 33 22 11, natalie.lorent@uzleuven.be
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Christina Thornton, MD, PhD, FRCPC, +1 403-220-5110, Christina.Thornton@albertahealthservices.ca
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Zagreb
Zagreb
Mateja Janković Makek, MD, PhD
Germany1 site, 1 recruiting
- Recruiting
University Hospital Frankfurt
Frankfurt
Nils Wetzstein
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, 6511LK
Arthur Lemson, MD, +31634265743, arthur.lemson@radboudumc.nl
Wouter Hoefsloot, MD, PhD, +31611072569, wouter.hoefsloot@radboudumc.nl
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Nakwon Kwak, n.kwak@snu.ac.kr
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Julian Gonzalez-Martin, MD, PhD, +34 932 27 54 00, GONZALEZ@clinic.cat
About this study
To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.
Read the detailed description
Mycobacterium avium complex (MAC) is the most frequent causative species that results in nontuberculous mycobacterial pulmonary disease (NTM-PD). Current treatment outcomes for MAC-PD are unsatisfactory with sputum culture conversion rates between 50-70%.The high prevalence of drug toxicity and low adherence to guideline-based treatment (GBT) are key reasons for the limited treatment success. Hence, there is an unmet need for prospective data on effectiveness of, adherence and adjustments to MAC-PD treatment regimens. By collaborating with NTM-NET and ESGMYC affiliated medical centers, we enable systematic, prospective data collection of an international MAC-PD cohort.
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture conversion rate
Conversion from positive cultures at baseline to negative cultures after 6 months of antimycobacterial treatment, defined by three or more negative sputum cultures sampled a month apart or one negative culture from a bronchial lavage.
Measured: 6 months
Secondary outcomes (6)
Change in mycobacterial load compared to baseline
Change in acid fast bacilli (AFB) smear determined by auramine staining
Measured: 6 months
Change in mycobacterial load compared to baseline
Change in time-to-positivity of positive cultures
Measured: 6 months
Change in symptoms compared to baseline
Change in symptoms as judged by the treating physician
Measured: 6 months
Adverse drug reactions to antimycobacterial treatment
Adverse drug reactions and the (assumed) causative antimycobacterial drug
Measured: 6 months
Antimycobacterial treatment adjustments
Any change in the antimycobacterial treatment including the reason
Measured: 6 months
Other treatment adjustments
Changes in concomitant medication, supportive care measures or a surgical intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium Complex Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakko van Ingen, MSc, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906316
- Sponsor's protocol ID
- 2022-13742
- Acronym
- MAC-PD cohort
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
- ClinicalTrials.gov ID
- NCT05906316
- Acronym / sponsor ID
- MAC-PD cohort / 2022-13742
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of treatment.
Detailed description
Mycobacterium avium complex (MAC) is the most frequent causative species that results in nontuberculous mycobacterial pulmonary disease (NTM-PD). Current treatment outcomes for MAC-PD are unsatisfactory with sputum culture conversion rates between 50-70%.The high prevalence of drug toxicity and low adherence to guideline-based treatment (GBT) are key reasons for the limited treatment success. Hence, there is an unmet need for prospective data on effectiveness of, adherence and adjustments to MAC-PD treatment regimens. By collaborating with NTM-NET and ESGMYC affiliated medical centers, we enable systematic, prospective data collection of an international MAC-PD cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Mycobacterium avium complex pulmonary disease that (MAC-PD) requires guideline-based three-drug antimycobacterial therapy. MAC is the most common causative species of pulmonary NTM infections.
Key inclusion criteria (2 listed)
- Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
- Signed and dated informed consent
Key exclusion criteria (9 listed)
- The participant is in poor general condition where participation in the study cannot be accepted per discretion of the Investigator
- The participant has a known or suspected, current drug or alcohol abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the patient
- HIV-infection;
- Cystic fibrosis;
- >1 month antibiotic treatment for current MAC infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Culture conversion rate
Time frame: 6 months
Conversion from positive cultures at baseline to negative cultures after 6 months of antimycobacterial treatment, defined by three or more negative sputum cultures sampled a month apart or one negative culture from a bronchial lavage.
6 secondary outcomes
Change in mycobacterial load compared to baseline
Time frame: 6 months
Change in mycobacterial load compared to baseline
Time frame: 6 months
Change in symptoms compared to baseline
Time frame: 6 months
Adverse drug reactions to antimycobacterial treatment
Time frame: 6 months
Antimycobacterial treatment adjustments
Time frame: 6 months
Other treatment adjustments
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakko van Ingen, MSc, PhD principal investigator
Radboud University Medical Center
11 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Avium Complex Pulmonary Disease, run by Radboud University Medical Center at 11 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, United States, Belgium, Canada, Croatia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur Lemson, MSc (+31634265743, arthur.lemson@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture conversion rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.