Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis
Information source: University Hospital, Geneva
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis
Phase: N/A
Status: Completed
Sponsored by: University Hospital, Geneva Official(s) and/or principal investigator(s):
Jean-Paul Janssens, M.D., Principal Investigator, Affiliation: Geneva University Hospital
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.
Clinical Details
Official title: Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis
Study design: Other, Prospective
Primary outcome: Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis
Detailed description:
Patients either treated for active culture proven tuberculosis (TB) or having completed
treatment during the preceding 6 months were recruited. Exclusion criteria were : HIV
infection and previous TB. Interferon gamma release assay (T-SPOT. TB, Oxford Immunotec) was
sampled during the 2 first weeks of treatment, at the end of treatment and 6 months later.
T-SPOT. TB was analysed qualitatively (pos/neg) and quantitatively (Spot forming units: SFU)
to determine if there was a higher rate of negative tests at the end of treatment and 6
months after treatment than initially. Paired samples were analysed to compare SFU counts
between beginning of treatment and end of treatment, and SFU counts between end of treatment
and 6 months later.
Clinical response to treatment was recorded, as well as treatment failures and relapses.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- culture proven tuberculosis
Exclusion Criteria:
- age < 18
- prior tuberculosis
- HIV infection
Locations and Contacts
Centre antituberculeux; Geneva University Hospital, Geneva, Geneva 14 1211, Switzerland
Additional Information
Related publications: 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. Epub 2007 May 30.
Starting date: October 2004
Ending date: July 2006
Last updated: January 7, 2008
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