Clofazimine for Mycobacterium Avium Complex Infection

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Kevin L Winthrop, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oregon Health and Science University

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD

Research Team

Kevin L Winthrop, MD, MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed consent for the use of study drug

My lung condition meets specific health standards.

I am 18 years old or older.

Exclusion Criteria

Pregnancy, or breastfeeding that will continue during treatment

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

Corrected QT (QTc) interval on electrocardiogram (ECG) > 470 ms for females or 450 ms for males, calculated using Fridericia's formula60,61

Treatment Details

Interventions

• Clofazimine (Anti-infective agent)

Trial Overview 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.

Participant Groups

Group I: clofazimine Experimental Treatment 1 Intervention

Participants receive lamprene

Group II: sugar pill Placebo Group 1 Intervention

Participants receive placebo

Clofazimine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Lamprene for:

• Leprosy

🇪🇺 Approved in European Union as Lamprene for:

• Leprosy

🇨🇦 Approved in Canada as Clofazimine for:

• Leprosy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Heart, Lung and Blood Institute Bethesda, MD

Oregon Health & Science University Portland, OR

University of Texas Health Science Center Tyler, TX

University of Chicago Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1024

Patients Recruited

7,420,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3361

Patients Recruited

5,516,000+

University of South Florida

Collaborator

Trials

433

Patients Recruited

198,000+

The University of Texas Health Science Center at Tyler

Collaborator

Trials

15

Patients Recruited

25,700+

University of Chicago

Collaborator

Trials

1086

Patients Recruited

844,000+

Temple University

Collaborator

Trials

321

Patients Recruited

89,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

National Jewish Health

Collaborator

Trials

145

Patients Recruited

318,000+

References