Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
Conditions
Brief summary
The MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M. avium complex lung infections.
Detailed description
The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary M. avium complex patients. Eligible patients who consent to participate will be randomized 1:1 to hypertonic saline or standard of care for 12 weeks. All patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks. Patients may continue with other airway clearance methods (i.e. flutter, acapella valve, aerobika, postural drainage, huff cough, percussion). Patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs. Patients may also be actively treated with inhaled corticosteroid at the time of enrollment, with dosing adjustments during the trial discouraged. Patients with disease progression at any time can be discontinued from the study treatment and treated according to ATS/IDSA guidelines at the discretion of the primary investigator. However, such patients will still complete the 12 week final visit, sputum collection and AE assessment.
Interventions
DRUGHypertonic saline
Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
DRUGAzithromycin
Standard of care
DRUGEthambutol
Standard of care
DRUGRifampin
Standard of care
Sponsors
NTM Info & Research, Inc.
University Health Network, Toronto
New York University
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization * Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria\[1\] * Age 18 and older * Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report * Ability to provide informed consent
Exclusion criteria
* Any patient who is unwilling or unable to provide consent or to comply with this protocol * Cavitary NTM disease * Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment * Diagnosis of HIV * Diagnosis of Cystic fibrosis * Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening * Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months * Prior lung or other solid organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Culture conversion | 12 weeks | At least two negative AFB cultures on different days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semi-quantitative culture results | 12 weeks | Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+). |
Countries
Canada, United States
Contacts
Primary ContactDaniel Bouchat
Backup ContactAlyssa Schroeder
Outcome results
None listed