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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0149

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Computerized Tomography;
Colony Forming Units;
Cystic Fibrosis;
Analysis of Variance;
Forced Expiratory Volume;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Mycobacterium Infections, Non-tuberculous

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

Subjects with PNTM must meet the following criteria to participate in this study:

1. Ages 18-99 years

2. Diagnosis of PNTM

3. Participating on an existing NIH protocol.

4. 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:

1. Ages 18-80 years

2. Healthy

3. Willing to have blood tests for CRP, Beta-2 M, ESR, and cytokine assessments in respiratory secretions and blood

4. Willing to donate respiratory secretions and blood to be used for future research

EXCLUSION CRITERIA:

Subjects with PNTM:

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 medications of colony stimulating factors, IFN-gamma, TNF-alpha 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:

a. Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 degrees Celsius) pulse less than 51 per minute or greater than 124 per minute

b. Respiratory rate less than 12 per minute or greater than 40 per minute.

c. Oxygen saturation less than 92 percent

4. New (less than or equal to 30 days) tracheostomy tube, chest tube, or major surgery.

5. 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:

a. Temperature (tympanic) greater than 101degrees Fahrenheit (38.3 o Celsius)

b. Pulse less than 51 per minute or greater than 124 per minute

c. Respiratory rate less than 12 per minute or greater than 40 per minute.

d. 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ann M. Peterson, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 5-5671
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1654
apeterson@cc.nih.gov

Ann M. Peterson, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 5-5671
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1654
apeterson@cc.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01150721

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