Mycobacterium Infections, Non-tuberculousNCT01150721
Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
An observational study of Mycobacterium Infections, Non-tuberculous, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mycobacterium Infections, Non-tuberculous
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy adult volunteers and adult patients with Nontuberculous Mycobacterial Infection
Who may be able to join
- 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:
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- 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
Who cannot join
- 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blood or respiratory (subjects able to provide blood and at least one type of respiratory secretions will not be withdrawn from the study)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.
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- 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:
- 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
- Respiratory rate less than 12 per minute or greater than 40 per minute.
- Oxygen saturation less than 92%
- Recent (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery.
- Current infection with tuberculosis
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Computerized Tomography, Colony Forming Units, Cystic Fibrosis, Analysis of Variance, Forced Expiratory Volume, Natural History
- Medical subject headings
- Mycobacterium Infections, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/PNMI | Adult patients with Pulmonary Nontuberculous Mycobacterial Infection | |
| 2/Healthy Volunteers | Healthy Volunteer adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare collection methods in respiratory secretions
Compare three standardized non-invasive collection methods for obtaining respiratory secretions
Measured: Day 1
Secondary outcomes (3)
Characterize subjects by phase of illness, status of medications and inflammation
Common blood laboratory tests of inflammation
Measured: Day 1
Compare molecular markers of inflammation
Expectorated and induced sputum, pharyngeal swabs, and blood in order to characterize inflammation in two groups of participants with PNTM: 1. patients currently culture positive for NTM infection, 2. patients currently NTM culture negative and in healthy volunteers
Measured: Day 1
Determine predictors for success with production of respiratory secretions
Expectorated and induced sputum
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study start10 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Infections, Non-tuberculousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven M Holland, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150721
- Sponsor's protocol ID
- 100149
- Other IDs
- 10-CC-0149
- Status last verified
- 2 Feb 2026
- First submitted
- 24 Jun 2010
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
- ClinicalTrials.gov ID
- NCT01150721
- Acronym / sponsor ID
- 100149
- Keywords
- Computerized Tomography, Colony Forming Units, Cystic Fibrosis, Analysis of Variance, Forced Expiratory Volume, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 10 Nov 2010 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/PNMI | – | –Adult patients with Pulmonary Nontuberculous Mycobacterial Infection |
| 2/Healthy Volunteers | – | –Healthy Volunteer adults |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers and adult patients with Nontuberculous Mycobacterial Infection
Key inclusion criteria (10 listed)
- 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).
- Ages 18-80 years
Key exclusion criteria (31 listed)
- 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:
- New (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery.
- Current infection with TB or HIV:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare collection methods in respiratory secretions
Time frame: Day 1
Compare three standardized non-invasive collection methods for obtaining respiratory secretions
3 secondary outcomes
Characterize subjects by phase of illness, status of medications and inflammation
Time frame: Day 1
Compare molecular markers of inflammation
Time frame: Day 1
Determine predictors for success with production of respiratory secretions
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven M Holland, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Infections, Non-tuberculous, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare collection methods in respiratory secretions (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.