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Completed

NCT Number: NCT00201253

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.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Enfermedades Respiratorias (INER), Mexico City, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoalveolar lavages and venipunctures only

Other

Primary outcomes

  1. Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)

    Time frame: one week

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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