Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
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|ClinicalTrials.gov Identifier: NCT01150721|
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : November 14, 2018
- 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.
- To compare throat cultures and coughed-up and induced phlegm or sputum in individuals with pulmonary nontuberculous mycobacterial infection and inflammation.
- 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.
- 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.
|Condition or disease|
|Pulmonary Nontuberculous Mycobaterium Infection|
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.
|Study Type :||Observational|
|Actual Enrollment :||177 participants|
|Official Title:||Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection|
|Study Start Date :||July 31, 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150721
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ann M Peterson, R.N.||National Institutes of Health Clinical Center (CC)|