Clinical trial NCT00201253: Expression of Tuberculosis in the Lung
Official title: Expression of Tuberculosis in the Lung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tuberculosis and household contacts of patients with tuberculosis.

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.

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

Primary outcomes:
measure: Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ-New Jersey Medical School
state: New Jersey
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias (INER)
Study officials:
affiliation: UMDNJ-New Jersey Medical School
name: Jerrold Ellner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1128/IAI.73.8.4505-4511.2005.