Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome (NCT05277857) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
United States109 participantsStarted 2020-09-20
Plain-language summary
Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome
Who can participate
Age range
18 Years
Sex
ALL
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:
* 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 particip…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.