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

This study has been completed.
Sponsor:
Collaborator:
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00595907
First received: January 7, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • culture proven tuberculosis

Exclusion Criteria:

  • age < 18
  • prior tuberculosis
  • HIV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595907

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Paul Janssens, MD
ClinicalTrials.gov Identifier: NCT00595907     History of Changes
Other Study ID Numbers: Janssens1/2008
Study First Received: January 7, 2008
Last Updated: January 7, 2008
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Interferon-gamma
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014