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Expression of Tuberculosis in the Lung

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ) Identifier:
First received: September 16, 2005
Last updated: January 22, 2015
Last verified: January 2015
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.

Condition Intervention
Tuberculosis Other: Bronchoalveolar lavages and venipunctures only

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Expression of Tuberculosis in the Lung

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline) [ Time Frame: one week ]

Biospecimen Retention:   Samples With DNA

Cell culture supernatants and cell lysates from bronchoalveolar cells, as well as peripheral blood mononuclear cells.

Bronchoalveolar lavage fluid

Enrollment: 40
Study Start Date: September 2000
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:


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.


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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tuberculosis and household contacts of patients with tuberculosis.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00201253

United States, New Jersey
UMDNJ-New Jersey Medical School
Newark, New Jersey, United States, 07103
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City, Mexico
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jerrold Ellner UMDNJ-New Jersey Medical School
  More Information

Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00201253     History of Changes
Other Study ID Numbers: 286
R01HL051630 ( U.S. NIH Grant/Contract )
Study First Received: September 16, 2005
Last Updated: January 22, 2015

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on July 21, 2017