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Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection

NCT01150721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

\- Pulmonary nontuberculous mycobacterial infection is a respiratory infection that is sometimes difficult to diagnose. Proper diagnosis depends on accurate collection of respiratory secretions, but these secretions may be contaminated by bacteria present in the mouth at the time of collection. In addition, some individuals may have difficulty providing respiratory secretions, because the infection affects lung function and sputum production. By collecting new samples from individuals who have already been diagnosed with this infection, and comparing the methods of collection, researchers hope to better understand and improve the ability to accurately diagnose and treat the infection at an early stage.

Objectives:

\- To compare throat cultures and coughed-up and induced phlegm or sputum in individuals with pulmonary nontuberculous mycobacterial infection and inflammation.

Eligibility:

\- Individuals between 18 and 79 years of age who have been diagnosed with pulmonary nontuberculous mycobacterial infection and are currently participating in selected NIH protocols on this infection.

Design:

* The study will require a single 90-minute visit to provide research specimens.
* Participants must not eat or drink for 2 hours prior to the collection of the early morning respiratory specimens. Blood pressure, temperature, pulse, breathing rate, and oxygen saturation level readings will be taken on the day of collection to ensure that participants may safely provide the specimens.
* Participants will provide the following samples:
* Blood sample: Participants will provide a blood sample to measure indicators of inflammation in the blood.
* Throat swab: Participants will brush their teeth thoroughly before allowing researchers to swab the inside of their throat with a sterile swab.
* Sputum collection (regular and induced): Participants will brush their teeth thoroughly and then provide both a regular sputum sample (produced normally) and an induced sputum sample (produced after using a nebulizer to stimulate sputum production).
* No treatment will be provided as part of this protocol.

Conditions

  • Mycobacterium Infections, Non-tuberculous

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Steven M Holland, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01150721 on ClinicalTrials.gov