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:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT05277857
Eligibility Criteria:
Inclusion Criteria:
* All subjects:
* Race/ethnicity: any
* Subject has no history of active Tuberculosis in the last 2 years.
* NTM culture positive from respiratory specimen (sputum or bronchial lavage fluid)
* Subject must have an available sputum sample that was taken in the last 2 years. If a sample is not available, the subject must be willing and able to provide a sputum sample.
* Meets the following Infectious Diseases Society of America (IDSA) criteria for NTM lung disease:
* 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "Mycobacterium Avium Complex" or "Mycobacterium abscessus) within the last 2 years.
* Nodules, cavities, and/or bronchiectasis on CT scan within the past 2 years
* If if the above data are not available, but a patient's Infectious Disease or Pulmonary physician has documented the diagnosis of NTM lung disease in their notes, this will suffice
PK subjects:
* Newly diagnosed with NTM lung disease and beginning antibiotics for NTM within the last 3 months from enrollment.
* Prior diagnosis of NTM lung disease, and starting initial therapy within the last 3 months prior to enrollment.
* Consent to pharmacokinetic testing within one month of enrollment and at six months of therapy
Exclusion Criteria:
* List the criteria for exclusion
All subjects:
* Age \< 18 years
* Subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia)
* Unable to participate in follow-up requirements by phone or clinic visit
PK subjects:
• Unable to have blood drawn for pharmacokinetic testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05277857
Study Brief:
Protocol Section:
NCT05277857