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Clinical trial

Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease

ID
Name
MAC-HS
Description
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.
Trial arms
Trial start
2021-05-18
Estimated PCD
2025-06-30
Trial end
2025-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Hypertonic saline
Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
Arms:
Hypertonic saline
Azithromycin
Standard of care
Arms:
Standard of Care
Ethambutol
Standard of care
Arms:
Standard of Care
Rifampin
Standard of care
Arms:
Standard of Care
Size
50
Primary endpoint
Culture conversion
12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-12-19

1 organization

1 product

2 indications

Organization
Oregon Health and Science University
Product
Hypertonic saline
Indication
Nontuberculous Mycobacterial Lung Disease
Indication
Nontuberculous Mycobacteria Infection