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Hope for Hard-to-Treat lung infection: old drug shows promise

NCT ID NCT02968212

Disease control Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called clofazimine for people with a chronic lung infection caused by Mycobacterium avium complex (MAC). The goal is to see if adding clofazimine to standard treatment helps clear the bacteria from sputum and improves walking ability and fatigue. About 102 adults with confirmed MAC lung disease are taking part. The drug is not a cure, but aims to better control the infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Apr 2017

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 2 positive MAC sputum cultures in the last 12 months with at least one obtained within 12 weeks prior to randomization * Meet ATS/IDSA 2007 pulmonary disease criteria * Adult males and females age 18 or over * Ability to provide informed consent for the use of study drug Exclusion Criteria: * 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 12 weeks received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC * Current usage of inhaled amikacin, tobramycin, or gentamicin * In the judgment of the investigator, the patient is not a candidate for observation (e.g. severe symptoms, extensive disease burden) but rather should be treated with standard multi-drug therapy * Prior use of clofazimine that has resulted in an allergy to clofazimine or a severe adverse reaction * Current usage of medications associated with QT prolongation (see Appendix C for full list of prohibited concomitant medications) * Corrected QT (QTc) interval on electrocardiogram (ECG) \> 470 ms for females or 450 ms for males, calculated using Fridericia's formula60,61 * Advanced lung disease (FEV\<30%) * HIV * Active pulmonary tuberculosis requiring treatment at screening * Active pulmonary malignancy or chemotherapy or radiation within 1 year of screening * Use of chronic systemic corticosteroids at doses of 15 mg/day for more than 12 weeks * Prior lung or other solid organ transplant * Pregnancy, or breastfeeding that will continue during treatment

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Conditions

The condition(s) this trial relates to.

Mycobacterium avium complex disease pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mycobacterium avium complex

Contacts and locations

Locations

  • Louisiana State University

    Baton Rouge, Louisiana, 70803, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of South Florida

    Tampa, Florida, 33620, United States

  • University of Texas Health Science Center

    Tyler, Texas, 75708, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.