A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study

Recruiting now

Conditions studied: Mycobacterium Avium Complex Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT05906316

Run by

Radboud University Medical Center

People needed

100

Starts

2023-07-01

Expected to finish

2026-07-01

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
• Signed and dated informed consent

You may not qualify if…

• 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
• 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;

Where it is running

• Oregon Science and Health University — Portland, Oregon, United States (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• University of Calgary — Calgary, Alberta, Canada (enrolling)
• University Hospital Center Zagreb — Zagreb, Croatia (enrolling)
• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Rasmus Rude Laub — Hellerup, Denmark (enrolling)
• University Hospital Frankfurt — Frankfurt, Germany (enrolling)
• Fukujuji Hospital — Tokyo, Japan (enrolling)
• Radboud University Medical Center — Nijmegen, Netherlands (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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