Clinical trial NCT00595907: Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis
Official title: Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: tuberculosis
interferon gamma release assays
treatment
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Ligue Pulmonaire Genevoise
First posted: 2008-01-16
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion

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.

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 criteria: Inclusion Criteria:

* culture proven tuberculosis

Exclusion Criteria:

* age \< 18
* prior tuberculosis
* HIV infection

Primary outcomes:
measure: Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis
timeFrame: 12-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Centre antituberculeux; Geneva University Hospital
state: Geneva 14
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Paul Janssens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bosshard 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.