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

NCT01150721 | Completed

• 2 other identifiers: 10014910-CC-0149
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Computerized Tomography; Colony Forming Units; Cystic Fibrosis; Analysis of Variance; Forced Expiratory Volume; Natural History

Outcome Measures

Primary Outcomes (1)

• Compare collection methods in respiratory secretions

  Compare three standardized non-invasive collection methods for obtaining respiratory secretions

  Day 1

Secondary Outcomes (3)

• Characterize subjects by phase of illness, status of medications and inflammation

  Day 1

• Compare molecular markers of inflammation

  Day 1

• Determine predictors for success with production of respiratory secretions

  Day 1

Study Arms (2)

1/PNMI

Adult patients with Pulmonary Nontuberculous Mycobacterial Infection

2/Healthy Volunteers

Healthy Volunteer adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers and adult patients with Nontuberculous Mycobacterial Infection

You may qualify if:

• Subjects with PNTM must meet the following criteria to participate in this study:
• 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).
• Healthy volunteers must meet the following criteria to participate in this study:
• 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

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.
• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Mycobacterium Infections; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Steven M Holland, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: November 10, 2010
• Last Updated: April 14, 2026

Record last verified: 2026-02-02

Locations

US (1)