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Expression of Tuberculosis in the Lung

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ClinicalTrials.gov Identifier: NCT00201253
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 26, 2015
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 )

Tracking Information
First Submitted Date September 16, 2005
First Posted Date September 20, 2005
Last Update Posted Date January 26, 2015
Study Start Date September 2000
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2015)
Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline) [ Time Frame: one week ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Expression of Tuberculosis in the Lung
Official Title Expression of Tuberculosis in the Lung
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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

Bronchoalveolar lavage fluid

Sampling Method Non-Probability Sample
Study Population Patients with tuberculosis and household contacts of patients with tuberculosis.
Condition Tuberculosis
Intervention Other: Bronchoalveolar lavages and venipunctures only
Study Groups/Cohorts Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2015)
40
Original Enrollment Not Provided
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00201253
Other Study ID Numbers 286
R01HL051630 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
Study Sponsor University of Medicine and Dentistry of New Jersey
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jerrold Ellner UMDNJ-New Jersey Medical School
PRS Account Rutgers, The State University of New Jersey
Verification Date January 2015