Hypertonic Saline for MAC

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: New York University; NTM Info & Research, Inc.; University Health Network, Toronto
• Treatments: Azithromycin; Ethambutol; Rifampin

Criteria

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