Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT02968212
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02968212
Study Brief:
Protocol Section:
NCT02968212