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)
Facility
City
Region
Status
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 Germany
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.