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| Sponsor: | University Hospital, Geneva |
|---|---|
| Collaborator: |
Ligue Pulmonaire Genevoise |
| Information provided by: | University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00595907 |
Purpose
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.
| Condition |
|---|
|
Tuberculosis |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis |
Peripheral blood lymphocytes cultured over-night; ELISPOT for detection of interferon-gamma production
| Enrollment: | 89 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland, Geneva 14 | |
| Centre antituberculeux; Geneva University Hospital | |
| Geneva, Geneva 14, Switzerland, 1211 | |
| Principal Investigator: | Jean-Paul Janssens, M.D. | Geneva University Hospital |
More Information
| Responsible Party: | ( Jean-Paul Janssens, MD ) |
| Study ID Numbers: | Janssens1/2008 |
| Study First Received: | January 7, 2008 |
| Last Updated: | January 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00595907 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
tuberculosis interferon gamma release assays treatment |
|
Bacterial Infections Anti-Infective Agents Gram-Positive Bacterial Infections Interferon Type II Antineoplastic Agents Therapeutic Uses |
Mycobacterium Infections Tuberculosis Antiviral Agents Pharmacologic Actions Actinomycetales Infections Interferon-gamma, Recombinant |
