Status:
COMPLETED
Comparing Expectorated and Induced Sputum and Pharyngeal Swabs for Cultures, AFB Smears, and Cytokines in Pulmonary Nontuberculous Mycobacterial Infection
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Mycobacterium Infections, Non-tuberculous
Eligibility:
All Genders
18-80 years
Brief Summary
Background: \- Pulmonary nontuberculous mycobacterial infection is a respiratory infection that is sometimes difficult to diagnose. Proper diagnosis depends on accurate collection of respiratory secr...
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 experien...
Eligibility Criteria
Inclusion
- 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.
- 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:
- 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blood or respiratory (subjects able to provide blood and at least one type of respiratory secretions will not be withdrawn from the study)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, 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.
- 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.
Exclusion
Key Trial Info
Start Date :
November 10 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01150721
Start Date
November 10 2010
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892