Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595907
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva

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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 89 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Primary Outcome Measures :
  1. Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis [ Time Frame: 12-18 months ]

Biospecimen Retention:   Samples Without DNA
Peripheral blood lymphocytes cultured over-night; ELISPOT for detection of interferon-gamma production

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion

Inclusion Criteria:

  • culture proven tuberculosis

Exclusion Criteria:

  • age < 18
  • prior tuberculosis
  • HIV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595907

Centre antituberculeux; Geneva University Hospital
Geneva, Geneva 14, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Ligue Pulmonaire Genevoise
Principal Investigator: Jean-Paul Janssens, M.D. University Hospital, Geneva

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean-Paul Janssens, MD Identifier: NCT00595907     History of Changes
Other Study ID Numbers: Janssens1/2008
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by University Hospital, Geneva:
interferon gamma release assays

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents