RecruitingNCT05906316
A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
Sponsor
Radboud University Medical Center
Enrollment
100 participants
Start Date
Jul 1, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria9
- 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;
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Locations(11)
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NCT05906316