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Completed

NCT Number: NCT00595907

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre antituberculeux; Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • culture proven tuberculosis

Exclusion criteria

  • age < 18
  • prior tuberculosis
  • HIV infection

Treatment and study plan

Primary outcomes

  1. Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis

    Time frame: 12-18 months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Ligue Pulmonaire Genevoise

Registry information

Official study title

Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 16, 2008
Registry last updated
Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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