Expression of Tuberculosis in the Lung

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00201253
First received: September 16, 2005
Last updated: May 24, 2013
Last verified: May 2013

September 16, 2005
May 24, 2013
September 2000
June 2008   (final data collection date for primary outcome measure)
Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)
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Complete list of historical versions of study NCT00201253 on ClinicalTrials.gov Archive Site
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Expression of Tuberculosis in the Lung
Expression of Tuberculosis in the Lung

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.

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.

Interventional
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Primary Purpose: Prevention
Tuberculosis
Biological: Bacille Calmette-Cuerin (BCG)
Not Provided
Rivas-Santiago B, Schwander SK, Sarabia C, Diamond G, Klein-Patel ME, Hernandez-Pando R, Ellner JJ, Sada E. Human {beta}-defensin 2 is expressed and associated with Mycobacterium tuberculosis during infection of human alveolar epithelial cells. Infect Immun. 2005 Aug;73(8):4505-11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00201253
286, R01HL051630, R01 HL051630
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University of Medicine and Dentistry New Jersey
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jerrold Ellner UMDNJ-New Jersey Medical School
Rutgers, The State University of New Jersey
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP