Expression of Tuberculosis in the Lung

This study has been completed.
Sponsor:
Collaborator:
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 )
ClinicalTrials.gov Identifier:
NCT00201253
First received: September 16, 2005
Last updated: January 22, 2015
Last verified: January 2015

September 16, 2005
January 22, 2015
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) [ Time Frame: one week ] [ Designated as safety issue: No ]
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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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

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

Bronchoalveolar lavage fluid

Non-Probability Sample
Patients with tuberculosis and household contacts of patients with tuberculosis.
Tuberculosis
Other: Bronchoalveolar lavages and venipunctures only
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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
40
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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00201253
286, R01HL051630
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University of Medicine and Dentistry of New Jersey
University of Medicine and Dentistry of 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
January 2015

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