A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
- Conditions
- Mycobacterium Avium Complex Pulmonary Disease
- Registration Number
- NCT05906316
- Lead Sponsor
- Radboud University Medical Center
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Newly diagnosed MAC-PD (primary or recurrent) as per the international NTM guideline that requires three-drug antimycobacterial treatment
- Signed and dated informed consent
- 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;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Other treatment adjustments 6 months Changes in concomitant medication, supportive care measures or a surgical intervention
Antimycobacterial treatment adjustments 6 months Any change in the antimycobacterial treatment including the reason
Adverse drug reactions to antimycobacterial treatment 6 months Adverse drug reactions and the (assumed) causative antimycobacterial drug
Change in mycobacterial load compared to baseline 6 months Change in time-to-positivity of positive cultures
Change in symptoms compared to baseline 6 months Change in symptoms as judged by the treating physician
Trial Locations
- Locations (10)
UZ Leuven
🇧🇪Leuven, Belgium
University of Calgary
🇨🇦Calgary, Alberta, Canada
Aarhus University Hospital
🇩🇰Arhus, Denmark
Rasmus Rude Laub
🇩🇰Hellerup, Denmark
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
Oregon Science and Health University
🇺🇸Portland, Oregon, United States
University Hospital Center Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Fukujuji Hospital
🇯🇵Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands