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

NCT ID: NCT00595907

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Tuberculosis

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* culture proven tuberculosis

Exclusion Criteria

* age \< 18
* prior tuberculosis
* HIV infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue Pulmonaire Genevoise

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Paul Janssens, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Centre antituberculeux; Geneva University Hospital

Geneva, Geneva 14, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 17537773 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18977647 (View on PubMed)

Other Identifiers

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Janssens1/2008

Identifier Type: -

Identifier Source: org_study_id

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