CompletedNot Applicable

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

United States177 participantsStarted 2010-11-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Ages 18-99 years
✓. Diagnosis of PNTM
✓. Participating on an existing NIH protocol.
✓. 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).
✓. Ages 18-80 years
✓. Healthy
✓. Willing to have blood tests for CRP, Beta-2 M, ESR, and cytokine assessments in respiratory secretions and blood
✓. Willing to donate respiratory secretions and blood to be used for future research

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)

What they're measuring

Compare collection methods in respiratory secretions

Timeframe: Day 1

Trial details

NCT IDNCT01150721

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

View on ClinicalTrials.gov More Mycobacterium Infections, Non-tuberculous trials