Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
Condition: Mycobacterium Infections, Non-tuberculous
MeSH terms: Infections; Communicable Diseases; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous
Study type: Observational

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.
    

Detailed description: 
      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 laboratory tests indicating
      inflammation include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and
      Beta-2-Microglobulin (Beta-2M). Patient assessments for dyspnea will be evaluated using the
      Borg questionnaire.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers and adult patients with Nontuberculous Mycobacterial Infection
      
Keywords: Computerized Tomography; Colony Forming Units; Cystic Fibrosis; Analysis of Variance; Forced Expiratory Volume; Natural History