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| Name | Class |
|---|---|
| NTM Info & Research, Inc. | UNKNOWN |
| University Health Network, Toronto | OTHER |
| New York University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline | Experimental | Patients who randomize to the hypertonic saline arm will be prescribed a nebulizer device to nebulize hypertonic saline (7%) twice daily for 12 weeks. Hypertonic saline (3%) can be prescribed in the case of poor tolerability of the 7% solution. |
|
| Standard of Care | Active Comparator | Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Drug | Nebulizing with 7% hypertonic saline twice daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Culture conversion | At least two negative AFB cultures on different days. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Semi-quantitative culture results | Evaluate acid fast bacilli (AFB) smear results to see if there is a decreased mycobacterial load (i.e. AFB smear 4+ decreasing to 3+). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Bouchat | Contact | 503-494-1859 | johdanie@ohsu.edu | |
| Alyssa Schroeder | Contact | 503-494-2136 | schroeder@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Active, not recruiting | New York | New York | 10016 | United States | |
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| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D017963 | Azithromycin |
| D004977 | Ethambutol |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004917 | Erythromycin |
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| Azithromycin | Drug | Standard of care |
|
| Ethambutol | Drug | Standard of care |
|
| Rifampin | Drug | Standard of care |
|
| Oregon Health & Science University |
| Recruiting |
| Portland |
| Oregon |
| 97239 |
| United States |
|
| University Health Network | Recruiting | Toronto | Ontario | ON M5G | Canada |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018942 |
| Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |