Clinical Trials

Inclusion Criteria:

MAC-PD Patients

• Patients and subjects 18 year or older regardless of disease severity, race, ethnicity, gender, pregnancy or nursing status.
• Guidelines-based diagnosis of MAC-PD (Daley CL, Iaccarino JM, Lange C, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline. Clin Infect Dis. 2020;71(4):905-913). All 3 criteria must be met to establish the clinical diagnosis and to warrant therapy:
  • Clinical AND radiographic findings consistent with MAC-PD, which can be variable including fibronodular or cavitary infiltrates on chest radiograph or chest computer tomography (CT); often with multifocal bronchiectasis and with multiple small nodules; right middle lobe and lingular region are commonly involved;
  • MAC growth in 2 or more sputa samples, 1 bronchial wash or bronchioalveolar lavage, or lung biopsy;
  • Exclusion of other diagnoses.
• Signed written informed consent for Mayo Clinic subjects, either willingly provided by the study subject or by a legal guardian/ representative.

Non-MAC-PD Control Subjects

• Patients and subjects 18 year or older regardless of disease severity, race, ethnicity, gender, pregnancy or nursing status. Patients will be matched for age, gender, race (i.e. matching within subject’s decade of age) and ethnicity.
• Mayo Clinic patients and subjects evaluated recently at Mayo Clinic campus and who meet the following conditions or diagnosis:
  • Asymptomatic subjects with a negative QuantiFERON Gold Plus test;
  • Asymptomatic subjects with diagnosis of LTBI that includes a positive results of a QuantiFERON Gold Plus test or similar Interferon-γ release assay AND a recent (within the last 6 months) chest radiograph showing no signs of active TB or other significant pulmonary abnormality;
  • Patients with diagnosed active tuberculosis within 1 month of guidance-based diagnosis (Lewinsohn, D. M.; Leonard, M. K.; LoBue, P. A.; et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clinical Infectious Diseases 2017).
• Signed written informed and HIPAA-compliant consent for Mayo Clinic subjects, willingly provided by the study subject, or by a legal guardian or representative willing and able to provide informed consent when the participant could not personally do so.

Exclusion Criteria:

• Patients younger than 18 years old.
• Patients unwilling or unable comply with the requirements of the study protocol.
• Patients or appropriate legal patient surrogates are unwilling or unable to give written informed consent and absence of a surrogate or representative.
• Recent diagnosis of COVID-19 pneumonia based on nasopharyngeal swab PCR results and within 21 days of enrollment.
• Subjects with immunosuppressed conditions (e.g. known HIV infection) and/or immunosuppressing medications (e.g., chronic prednisone > 5mg/day for > 3 weeks, Tumor necrosis factor-α antagonist therapy, or others as per current CDC criteria for immunosuppressive conditions).
• Unstable clinical condition (e.g. hospitalized patient transferring to or receiving care in an intensive care unit).
• Patients with disseminated MAC infections or multiorgan MAC infections.
• Patients diagnosed with cystic fibrosis (CF) given the unique pathophysiologic features for these patients in comparison with the heterogeneous group of patients with non-CF bronchiectasis at risk of MAC-PD.
• Patients with history of treatment failure to guidelines-compliant MAC-PD therapy that meets definitions outlined by the NTM Network European Trials group (NTM-NET)(van Ingen, J. et al. Treatment outcome definitions in nontuberculous mycobacterial pulmonary disease: an NTM-NET consensus statement. Eur Respir J, 2018).
• Anticipated lung surgery for the treatment of MAC-PD.
• Co-existent M abscessus complex (MAbsC) pulmonary disease with multiple and persistent MAbsC isolates in respiratory mycobacterial cultures.
• Patients diagnosed with concomitant severe pulmonary infection with other pathogen(s) including bacterial empyema or fungal infections.
• Refractory cough related to non-MAC-PD conditions such as severe GERD or interstitial lung disease.
• Patients with active malignancies, including primary or metastatic lung malignancies that require or would require radiation therapy or chemotherapy within 6 months of study enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/25/23. Questions regarding updates should be directed to the study team contact.