Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC) (NCT02968212) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)
United States102 participantsStarted 2017-04-11
Plain-language summary
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 can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
Change from Baseline sputum culture at 24 weeks
Timeframe: Sputum examined for culture change from Baseline at 24 weeks