Clofazimine for Mycobacterium Avium Complex Infection

Recruiting at 6 trial locations

Overseen By Daniel Bouchat

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oregon Health and Science University

Must not be taking: Bedaquiline, Macrolide, Ethambutol, others

Disqualifiers: Cavitary NTM, Advanced lung disease, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

102 Participants Needed

What You Need to Know Before You Apply

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

Who Is on the Research Team?

Kevin L Winthrop, MD, MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

At least 2 positive MAC sputum cultures in the last 12 months with at least one obtained within 12 weeks prior to randomization

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either clofazimine or placebo for 6 months

24 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clofazimine

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

The University of Texas Health Science Center at Tyler

Collaborator

Trials

15

Recruited

25,700+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+