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Scientists launch major study to unravel mysteries of rare lung infections

NCT ID NCT00018044

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 18 times

Summary

This study aims to learn more about non-tuberculous mycobacterial (NTM) infections, which cause repeated lung and other organ infections. Researchers will study up to 1,000 participants to understand the genetics, symptoms, and best treatments for these infections. The study also compares NTM with similar conditions like Job syndrome and cystic fibrosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clofazimine
What this could lead to
If successful, this study could improve understanding of why some people get these infections and point toward better treatments.
What could go wrong
This is an observational study focused on collecting data, not testing a new cure. It may not lead to immediate treatments.

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

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2001

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with mycobacterial infections, including those without previously identified predisposing disease processes as well as individuals with underlying malignancies. Patients with nontuberculous mycobacterial infections will be of particular interest but select patients with acquired immunodeficiencies or tuberculosis may also be studied if relevant host defects are suspected. We may obtain specimens from some blood relatives of enrolled patients.

Ages

Up to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 FOR PATIENTS: This protocol will study patients with mycobacterial infections, including those without previously identified predisposing disease processes as well as individuals with underlying malignancies. Patients with nontuberculous mycobacterial infections will be of particular interest, as we are interested in isolating and characterizing the primary immune defect(s) responsible for this infection susceptibility. Select patients with acquired immunodeficiencies or tuberculosis may also be studied if relevant host defects are suspected. Patients must be referred to NIH with a diagnosis or suspicion of having mycobacterial infection. Male and female patients will be accepted without limitation due to age, including viable neonates. Only patients with nontuberculous mycobacterial infections without HIV infection will be considered for long-term disease management. INCLUSION CRITERIA FOR RELATIVES: As a part of this protocol we may obtain medical records, blood work, urine, saliva or buccal swab from some blood relatives of patients, male or female including viable neonates, on the study, with the hope of isolating and characterizing the primary immune defect(s) responsible for mycobacterial infection susceptibility and if there are any genetic links seen within families. We hope to identify families with an apparent genetic susceptibility to respiratory diseases predominantly associated with P-NTM and perform whole genome sequencing within this group to identify genetic mutations accounting for this increased susceptibility. EXCLUSION CRITERIA: None.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis hyper-IgE recurrent infection syndrome 1, autosomal dominant mycobacterial infectious disease Mycobacterium avium complex disease Mycobacterium Infections, Nontuberculous pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

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

Mycobacterium infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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