Patient Reported Outcomes of Nontuberculous Mycobacterial Pulmonary Disease

Overview

About this study

The purpose of this study is e to better understand the trajectory of patient-reported outcomes (PROs), e.g. respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD). Secondary objectives are to create a data repository to be linked to future claims, electronic health record, and/or other existing databases and a biorepository of blood samples.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

All Cohorts

  • Willingness and ability to complete surveys.
  • English-speaking.

Cohort 1 (NTM-WATCH) additional criteria

  • First positive sputum or bronchoalveolar lavage AFB culture for M. avium complex or M. abscessus within the prior 4 months.

Cohort 2 (NTM-TREAT) additional criteria Inclusion

  • Meet ATS/IDSA disease criteria for M. avium complex or M. abscessus pulmonary disease10 , including the following:
    • At least 2 sputum or 1 bronchoalveolar lavage AFB culture positive for M. avium complex or M. abscessus;
    • Respiratory symptoms;
    • Nodular-bronchiectatic or cavitary disease on CT scan within prior 6 months.
  • Initiating ATS/IDSA guideline-based anti-mycobacterial therapy for NTM pulmonary disease Inclusion • Within 3 months of treatment stop, after at least 6 months of guideline-based anti-mycobacterial therapy for MAC or MAB pulmonary disease.

Cohort 3 (NTM-TRACK) additional criteria

  • Within 3 months of treatment stop, after at least 6 months of guideline-based anti-mycobacterial therapy for MAC or MAB pulmonary disease.

Exclusion Criteria:

All Cohorts

  •  Cystic fibrosis, not on modulator therapy for at least 3 months prior to enrollment.

Cohort 1 (NTM-WATCH) additional criteria

  • No prior history of positive AFB respiratory culture with the same species.
  • Plan to start treatment for MAC or MAB pulmonary disease.

Cohort 2 (NTM-TREAT) additional criteria Inclusion

  • More than 4 weeks of anti-mycobacterial therapy during the prior 2 years.

Cohort 3 (NTM-TRACK) additional criteria

  • No additional exclusions.

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

Eligibility last updated 9/28/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Open for enrollment

Contact information:

Kayla Quinn

(507) 538-0595

MacDonald.Kayla@mayo.edu

More information

Publications

Publications are currently not available