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

Completed

Conditions studied: Mycobacterium Infections, Non-tuberculous

In brief

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.

Key facts

Study ID: NCT01150721
Run by: National Institutes of Health Clinical Center (CC)
People needed: 177
Starts: 2010-11-10
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Subjects with PNTM:
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)
Current medications of colony stimulating factors, IFN-gamma, IFN-alpha or monoclonal antibodies such as Rituximab within three months of this study
Vital signs falling beyond the following parameters prior to specimen collection procedures:
Temperature (tympanic) greater than 101 degrees Fahrenheit (38.3 degrees Celsius) pulse less than 51 per minute or greater than 124 per minute
Respiratory rate less than 12 per minute or greater than 40 per minute.
Oxygen saturation less than 92 percent
New (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery.
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:
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)
Current use of specific biological medications: colony stimulating factors, IFN- >=, IFN- or monoclonal antibodies such as Rituximab within three months of this study
Vital signs falling beyond the following parameters prior to specimen collection procedures:
Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 o Celsius)
Pulse less than 51 per minute or greater than 124 per minute
Respiratory rate less than 12 per minute or greater than 40 per minute.
Oxygen saturation less than 92%
Recent (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery.
Current infection with tuberculosis
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.
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).

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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