Tuberculosis
Conditions
Brief summary
The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium tuberculosis in households of patients with TB or who are unexposed.
Detailed description
BACKGROUND: M. tuberculosis infects a third of the world's population, and TB is the leading cause of morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. Therefore protective immunity is induced in the majority of subjects. Understanding correlates of protection against M. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines. DESIGN NARRATIVE: Patients are treated according to good clinical practice; however, no study medications are given as part of the research study. This study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.
Interventions
OTHERBronchoalveolar lavages and venipunctures only
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Medicine and Dentistry of New Jersey
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* TB patients who are 18 to 65 years old * Clinical and radiographic signs and symptoms consistent with pulmonary TB * Start date of antituberculous chemotherapy less than 10 days prior to procedures * Sputum smear positive for acid fast bacilli * Drug-sensitive, culture-confirmed growth of M. tuberculosis from sputum * Willing to provide informed consent for participation in bronchoalveolar lavage and venipuncture studies
Exclusion criteria
* TB patients who have HIV-1 coinfection * History of any chronic medical condition requiring daily medication (including diabetes mellitus, hypertension, chronic infections, renal or cardiac failure, and peptic ulcer disease) * History of asthma or upper or lower respiratory tract infection within 2 months of the study * Hemoglobin level less than 10g/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline) | one week |
Countries
Mexico, United States
Outcome results
None listed