RECRUITING

Hypertonic Saline for MAC

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Conditions

Nontuberculous Mycobacterial Lung DiseaseNontuberculous Mycobacterium Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-05-18
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04921943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria\[1\]
  3. * Age 18 and older
  4. * Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report
  5. * Ability to provide informed consent
  1. * Any patient who is unwilling or unable to provide consent or to comply with this protocol
  2. * Cavitary NTM disease
  3. * 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
  4. * Diagnosis of HIV
  5. * Diagnosis of Cystic fibrosis
  6. * Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
  7. * Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
  8. * Prior lung or other solid organ transplant

Contacts and Locations

Study Contact

Daniel Bouchat
CONTACT
503-494-1859
johdanie@ohsu.edu
Haley Miller
CONTACT
503-346-1548
millehal@ohsu.edu

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-18
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-05-18
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Nontuberculous Mycobacterial Lung Disease
  • Nontuberculous Mycobacterium Infection