Health TrialsbyHealthPanel

Hypertonic Saline for MAC

ConditionsNontuberculous Mycobacterial Lung DiseaseNontuberculous Mycobacterium Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypertonic saline

    Drug

    Nebulizing with 7% hypertonic saline twice daily for 12 weeks.

  • Azithromycin

    Drug

    Standard of care

  • Ethambutol

    Drug

    Standard of care

  • Rifampin

    Drug

    Standard of care

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Hypertonic salineExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Culture conversion

At least two negative AFB cultures on different days.

Time frame
12 weeks

Secondary outcomes

1

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+).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

NTM Info & Research, Inc.

Collaborator

University Health Network, Toronto

Collaborator

New York University

Collaborator

Source ClinicalTrials.gov
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