Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis
Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis
1 other identifier
observational
89
1 country
1
Brief Summary
New blood tests have become available to detect either latent or active tuberculosis. These tests - which according to the CDC can replace the tuberculin skin test - measure the production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria responsible for tuberculosis). Our hypothesis was that the production of gamma-interferon would be much higher at the beginning of treatment than at the end, and that decline in gamma-interferon secretion could be an indicator of clinical response to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2004
1 active site
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
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedJanuary 16, 2008
January 1, 2008
1.7 years
January 7, 2008
January 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis
12-18 months
Eligibility Criteria
Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion
You may qualify if:
- culture proven tuberculosis
You may not qualify if:
- age \< 18
- prior tuberculosis
- HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- Ligue Pulmonaire Genevoisecollaborator
Study Sites (1)
Centre antituberculeux; Geneva University Hospital
Geneva, Geneva 14, 1211, Switzerland
Related Publications (2)
Janssens JP, Roux-Lombard P, Perneger T, Metzger M, Vivien R, Rochat T. Quantitative scoring of an interferon-gamma assay for differentiating active from latent tuberculosis. Eur Respir J. 2007 Oct;30(4):722-8. doi: 10.1183/09031936.00028507. Epub 2007 May 30.
PMID: 17537773BACKGROUNDBosshard V, Roux-Lombard P, Perneger T, Metzger M, Vivien R, Rochat T, Janssens JP. Do results of the T-SPOT.TB interferon-gamma release assay change after treatment of tuberculosis? Respir Med. 2009 Jan;103(1):30-4. doi: 10.1016/j.rmed.2008.09.012. Epub 2008 Nov 1.
PMID: 18977647DERIVED
Biospecimen
Peripheral blood lymphocytes cultured over-night; ELISPOT for detection of interferon-gamma production
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Paul Janssens, M.D.
University Hospital, Geneva
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
October 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 16, 2008
Record last verified: 2008-01