Expression of Tuberculosis in the Lung

Tuberculosis Clinical Trial

Official title:

Expression of Tuberculosis in the Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201253
• Other study ID #: 286
• Secondary ID: R01HL051630
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: January 22, 2015
• Start date: September 2000
• Est. completion date: June 2008

Study information

• Verified date: January 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Bronchoalveolar lavages and venipunctures only

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias (INER)	Mexico City
United States	UMDNJ-New Jersey Medical School	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)		one week	No