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Scientists compare sputum collection methods to improve diagnosis of lung infection

NCT ID NCT01150721

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 01, 2026 · Updated 18 times

Summary

This study looked at different ways to collect sputum (phlegm) from people with a lung infection called nontuberculous mycobacterial (NTM) infection. The goal was to see which method gives the best samples for diagnosing and understanding the infection. Participants provided throat swabs, coughed-up sputum, and sputum produced after using a nebulizer. No treatment was given; the study only compared collection methods.

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Study facts

What this study's own registry entry says, in plain language.

Participants

177 people

The number who actually took part.

Started

Nov 2010

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

Healthy adult volunteers and adult patients with Nontuberculous Mycobacterial Infection

Ages

18 to 80 years

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: Subjects with PNTM must meet the following criteria to participate in this study: 1. Ages 18-99 years 2. Diagnosis of PNTM 3. Participating on an existing NIH protocol. 4. Willing to allow the proposed protocol to use test results from the protocols. These data include: AFB smear and NTM cultures, HIV testing by ELISA and Western blot testing, CRP, ESR, \& Beta-2M, FEV1, and Borg Questionnaire results (Appendices E). Healthy volunteers must meet the following criteria to participate in this study: 1. Ages 18-80 years 2. Healthy 3. Willing to have blood tests for CRP, Beta-2 M, ESR, and cytokine assessments in respiratory secretions and blood 4. Willing to donate respiratory secretions and blood to be used for future research EXCLUSION CRITERIA: Subjects with PNTM: 1. Inability or unwillingness to provide any specimens: blood or respiratory (subjects able to provide blood and at least one type of respiratory secretions will not be withdrawn from the study) 2. Current medications of colony stimulating factors, IFN-gamma, IFN-alpha or monoclonal antibodies such as Rituximab within three months of this study 3. Vital signs falling beyond the following parameters prior to specimen collection procedures: 1. Temperature (tympanic) greater than 101 degrees Fahrenheit (38.3 degrees Celsius) pulse less than 51 per minute or greater than 124 per minute 2. Respiratory rate less than 12 per minute or greater than 40 per minute. 3. Oxygen saturation less than 92 percent 4. New (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery. 5. Current infection with TB or HIV: * Any condition in the judgment of the investigators that would place subjects at risk or would jeopardize the study. HEALTHY VOLUNTEER PARTICIPANT EXCLUSION CRITERIA: 1. Inability or unwillingness to provide any specimens: blood or respiratory (subjects able to provide blood and at least one type of respiratory secretions will not be withdrawn from the study) 2. Current use of specific biological medications: colony stimulating factors, IFN- \>=, IFN- or monoclonal antibodies such as Rituximab within three months of this study 3. Vital signs falling beyond the following parameters prior to specimen collection procedures: 1. Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 o Celsius) 2. Pulse less than 51 per minute or greater than 124 per minute 3. Respiratory rate less than 12 per minute or greater than 40 per minute. 4. Oxygen saturation less than 92% 4. Recent (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery. 5. Current infection with tuberculosis 6. History of chronic lung disease associated with increased inflammation to include: asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, or any lung condition that, in the opinion of the investigator, may potentially be associated with an increased pulmonary inflammatory response. 7. Any condition in the judgment of the investigators that would place subjects at risk or would jeopardize the study. Participation of Women: Contraception: -The protocol has no requirement for contraception or restriction due to contraception choice as the study interventions (blood draw and collection of respiratory secretions have no restriction relative to contraception). Pregnancy: -The protocol has no requirement for restriction due to pregnancy. Study interventions (blood draw and collection of respiratory secretions have no restrictions relative to pregnancy. Participation of Minorities: -There are no restrictions for minority participation in this study. Participation of Children: -Children are not included in this study since the benefit versus the procedural burden of the protocol does not support their inclusion. Asking children to produce three respiratory specimens at a protocol visit is thought to be burdensome. Infants and young children cannot spontaneously expectorate. The main protocol upon which this protocol recruits only includes adults.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States