Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis
|Study Design:||Time Perspective: Prospective|
|Official Title:||Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis|
- Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2004|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595907
|Centre antituberculeux; Geneva University Hospital|
|Geneva, Geneva 14, Switzerland, 1211|
|Principal Investigator:||Jean-Paul Janssens, M.D.||Geneva University Hospital|