Hypertonic Saline for MAC

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Jun 4, 2021

Keywords

ClinConnect Summary

The MAC-HS study is a clinical trial that is testing whether a treatment called hypertonic saline can help improve symptoms and clear infections caused by a type of bacteria known as M. avium complex (MAC) in the lungs. This study is for adults aged 18 and older who have been diagnosed with lung infections related to MAC and have had at least two positive tests for this bacteria in the past year. To be eligible, participants should also have signs of bronchiectasis, a condition that affects the airways in the lungs, as seen on a chest scan.

If you join this trial, you will be monitored closely to see how hypertonic saline affects your symptoms and the presence of the bacteria. However, there are certain conditions that would exclude someone from participating, such as having active tuberculosis or other specific lung diseases, recent use of certain medications for MAC, or a history of lung transplants. The study is currently recruiting participants, and if you're interested, it's important to talk to your doctor to see if you might qualify.

Gender

ALL

Eligibility 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