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Virginia study decodes why NTM lung infections return

NCT ID NCT05277857

Knowledge-focused Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at 109 people in Virginia with nontuberculous mycobacterial (NTM) lung disease. Researchers use genetic sequencing to tell if a repeat infection is a relapse or a new infection from the environment. The goal is to better understand how the disease comes back and improve treatment decisions.

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.

Participants

109 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jun 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.

Who is studied

Observational study of patients with Nontuberculous Mycobacterial lung disease. A subset of newly and prior diagnosed NTM lung disease patients, that have started initial therapy within the last 3 months, and prior diagnosed NTM lung disease patients who have not been on therapy for at least 5 years, will be enrolled in the pharmacokinetics study (Aim 2).

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: * 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

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Conditions

The condition(s) this trial relates to.

pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

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

Nontuberculous mycobacterial lung disease

Contacts and locations

Locations

  • University of Virginia, Division of Infectious Disease

    Charlottesville, Virginia, 22908, United States

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