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.
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 Type
OBSERVATIONAL
Enrollment
100
Oregon Science and Health University
Portland, Oregon, United States
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGCulture 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.
Time frame: 6 months
Change in mycobacterial load compared to baseline
Change in acid fast bacilli (AFB) smear determined by auramine staining
Time frame: 6 months
Change in mycobacterial load compared to baseline
Change in time-to-positivity of positive cultures
Time frame: 6 months
Change in symptoms compared to baseline
Change in symptoms as judged by the treating physician
Time frame: 6 months
Adverse drug reactions to antimycobacterial treatment
Adverse drug reactions and the (assumed) causative antimycobacterial drug
Time frame: 6 months
Antimycobacterial treatment adjustments
Any change in the antimycobacterial treatment including the reason
Time frame: 6 months
Other treatment adjustments
Changes in concomitant medication, supportive care measures or a surgical intervention
Time frame: 6 months
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University of Calgary
Calgary, Alberta, Canada
University Hospital Center Zagreb
Zagreb, Croatia
RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGRasmus Rude Laub
Hellerup, Denmark
RECRUITINGUniversity Hospital Frankfurt
Frankfurt, Germany
RECRUITINGFukujuji Hospital
Tokyo, Japan
RECRUITINGRadboud University Medical Center
Nijmegen, Netherlands
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING...and 1 more locations