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Recruiting Observational

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

NCT05906316 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-07-01
Last updated
2026-09-15

Condition(s) studied

Mycobacterium Avium Complex Pulmonary Disease

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment * Signed and dated informed consent Exclusion Criteria: * 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;

Primary outcome measure(s)

  • Culture conversion rate — 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.

Trial sites (11)

FacilityCityRegionStatus
Oregon Science and Health University Portland Oregon Recruiting
UZ Leuven Leuven Belgium Recruiting
University of Calgary Calgary Alberta Recruiting
University Hospital Center Zagreb Zagreb Croatia Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Rasmus Rude Laub Hellerup Denmark Recruiting
University Hospital Frankfurt Frankfurt Germany Recruiting
Fukujuji Hospital Tokyo Japan Recruiting
Radboud University Medical Center Nijmegen Netherlands Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Hospital Clínic de Barcelona Barcelona Spain Recruiting

More Radboud University Medical Center trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05906316 on ClinicalTrials.gov ↗ ← All trials in Spain