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Anti-infective agent

Clofazimine for Mycobacterium Avium Complex Infection

Phase 2

Recruiting

Led By Kevin Winthrop, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet ATS/IDSA 2007 pulmonary disease criteria

Be older than 18 years old

Must not have

Current usage of medications associated with QT prolongation (see Appendix C for full list of prohibited concomitant medications)

Advanced lung disease (FEV<30%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up promis fatigue 7a short form results examined for change from baseline at 24 weeks

Summary

This trial will test the effectiveness and safety of clofazimine to treat MAC lung disease.

Who is the study for?

Adults over 18 with pulmonary Mycobacterium Avium Complex (MAC) infection, who've had at least two positive MAC sputum cultures in the past year are eligible. They must be able to consent and not have severe lung disease, HIV, active tuberculosis or cancer treatments within a year, high heart rhythm risk (QT prolongation), or use certain drugs.

What is being tested?

The trial is testing clofazimine's effectiveness and safety against a sugar pill for treating MAC lung disease. Participants will randomly receive either clofazimine or a placebo to compare outcomes between the two groups.

What are the potential side effects?

Clofazimine may cause side effects like stomach pain, nausea, skin discoloration and itching. It can also potentially affect heart rhythms and interact with other medications leading to more serious issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung condition meets specific health standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that can affect my heart's rhythm.

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My lung function is severely reduced.

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I am currently being treated for active tuberculosis.

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I have had a lung or other solid organ transplant.

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I have been taking more than 15 mg/day of corticosteroids for over 12 weeks.

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I am currently using inhaled antibiotics like amikacin, tobramycin, or gentamicin.

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I am allergic to or had a severe reaction to clofazimine.

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I have taken specific antibiotics for MAC in the last 3 months.

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I have a lung condition with air-filled spaces caused by an infection.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ promis fatigue 7a short form results examined for change from baseline at 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~promis fatigue 7a short form results examined for change from baseline at 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and promis fatigue 7a short form results examined for change from baseline at 24 weeks for reporting.