Expression of Tuberculosis in the Lung
2 other identifiers
observational
40
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2000
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJanuary 26, 2015
January 1, 2015
7.8 years
September 16, 2005
January 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pulmonary immune responses associated with resistance and susceptibility to Mycobacterium tuberculosis infection (measured at baseline)
one week
Interventions
Eligibility Criteria
Patients with tuberculosis and household contacts of patients with tuberculosis.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UMDNJ-New Jersey Medical School
Newark, New Jersey, 07103, United States
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City, Mexico
Related 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. doi: 10.1128/IAI.73.8.4505-4511.2005.
PMID: 16040961BACKGROUND
Biospecimen
Cell culture supernatants and cell lysates from bronchoalveolar cells, as well as peripheral blood mononuclear cells. Bronchoalveolar lavage fluid
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold Ellner
UMDNJ-New Jersey Medical School
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
September 1, 2000
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 26, 2015
Record last verified: 2015-01