Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/10/2019 |
| Start Date: | July 31, 2010 |
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.
- 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.
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.
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.
- INCLUSION CRITERIA:
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 under Principle Investigators Kenneth
Olivier MD and Steven Holland MD
- Willing to allow the proposed protocol to use test results from the protocols of
Kenneth Olivier MD and Steven Holland. 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.
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
EXCLUSION CRITERIA:
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, TNF-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:
1. Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 degrees Celsius)
pulse less than 51 per minute or greater than 124 per minute
2. Respiratory rate less than 12 per minute or greater than 40 per minute.
3. 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.
HEALTHY VOLUNTEER PARTICIPANT EXCLUSION CRITERIA:
1. 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)
2. Current use of specific biological medications: colony stimulating factors, IFN- >=,
IFN- or monoclonal antibodies such as Rituximab within three months of this study
3. Vital signs falling beyond the following parameters prior to specimen collection
procedures:
1. Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 o Celsius)
2. Pulse less than 51 per minute or greater than 124 per minute
3. Respiratory rate less than 12 per minute or greater than 40 per minute.
4. Oxygen saturation less than 92%
4. Recent (less than or equal to 30 days) tracheostomy tube, chest tube, or major
surgery.
5. Current infection with tuberculosis
6. History of chronic lung disease associated with increased inflammation to include:
asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, or any lung
condition that, in the opinion of the investigator, may potentially be associated with
an increased pulmonary inflammatory response.
7. Any condition in the judgment of the investigators that would place subjects at risk
or would jeopardize the study.
Participation of Women:
Contraception:
-The protocol has no requirement for contraception or restriction due to contraception
choice as the study interventions (blood draw and collection of respiratory secretions
have no restriction relative to contraception).
Pregnancy:
-The protocol has no requirement for restriction due to pregnancy. Study interventions
(blood draw and collection of respiratory secretions have no restrictions relative to
pregnancy.
Participation of Minorities:
-There are no restrictions for minority participation in this study.
Participation of Children:
-Children are not included in this study since the benefit versus the procedural
burden of the protocol does not support their inclusion. Asking children to produce
three respiratory specimens at a protocol visit is thought to be burdensome. Infants
and young children cannot spontaneously expectorate. The main protocol upon which this
protocol recruits only includes adults.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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