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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mycobacterial load compared to baseline | Change in acid fast bacilli (AFB) smear determined by auramine staining | 6 months |
| Change in mycobacterial load compared to baseline | Change in time-to-positivity of positive cultures |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur Lemson, MSc | Contact | +31634265743 | arthur.lemson@radboudumc.nl | |
| Wouter Hoefsloot, MSc, PhD | Contact | +31611072569 | wouter.hoefsloot@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jakko van Ingen, MSc, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Science and Health University | Recruiting | Portland | Oregon | 97239 | United States |
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| 6 months |
| Change in symptoms compared to baseline | Change in symptoms as judged by the treating physician | 6 months |
| Adverse drug reactions to antimycobacterial treatment | Adverse drug reactions and the (assumed) causative antimycobacterial drug | 6 months |
| Antimycobacterial treatment adjustments | Any change in the antimycobacterial treatment including the reason | 6 months |
| Other treatment adjustments | Changes in concomitant medication, supportive care measures or a surgical intervention | 6 months |
| UZ Leuven | Recruiting | Leuven | Belgium |
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| University of Calgary | Recruiting | Calgary | Alberta | Canada |
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| University Hospital Center Zagreb | Recruiting | Zagreb | Croatia |
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| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
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| Rasmus Rude Laub | Recruiting | Hellerup | Denmark |
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| University Hospital Frankfurt | Recruiting | Frankfurt | Germany |
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| Fukujuji Hospital | Recruiting | Tokyo | Japan |
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| Radboud University Medical Center | Recruiting | Nijmegen | 6511LK | Netherlands |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Hospital Clínic de Barcelona | Recruiting | Barcelona | Spain |
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