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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.
• Pa
  

  Detailed Summary:

  In this protocol, a repeated measure design is used to examine microbial and molecular results in subjects with a diagnosis of pulmonary nontuberculous mycobacterial infection. Patients often experience difficulties in the spontaneous expectoration of sputum free from contamination with oral flora which contributes to the poor quality of some respiratory specimens sent to the laboratory. At present, it is not known how induced sputum, expectorated sputum, and pharyngeal swabs compare for acid fast bacilli (AFB) smear and culture results. Appropriate specimens are needed in the clinical setting for optimum diagnosis. In this study, procedures for the non-invasive collection of respiratory secretions will be used to decrease risk of specimen contamination.

  Subjects who cannot produce respiratory secretions will be compared to patients who are successful. It is not known which factors prevent production of respiratory secretions for testing. Airway inflammation may contribute to difficulty in producing sputum along with dyspnea, phase of illness (newly diagnosed or chronic infection), treatment status, and respiratory condition severity.

  Subjects will be characterized by phase of illness determined by health history and inflammation using common laboratory tests of inflammation. Respiratory specimens and blood will be collected for microbial testing and a portion will be stored then tested for analysis of pro-inflammatory cytokines (IL-1, IL-6, IL-8, TNF-alpha, & IFN-gamma). Clinical, demographic, laboratory, and patient subjective variables will be tested using regression statistical methods to determine predictors for specimen production success. Clinical variables to be tested include forced expiratory volume at one minute (FEV1) from a pulmonary function test (PFT), phase of illness and treatment, and age. The laborat
  Sponsor: National Institutes of Health Clinical Center (CC)
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: June 24, 2010
  Date Started: June 18, 2010
  Date Completion:
  Last Updated: April 20, 2017
  Last Verified: December 5, 2016