TuberculosisNCT00595907
Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis
An observational study of Tuberculosis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 89 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion
Who may be able to join
- culture proven tuberculosis
Who cannot join
- age < 18
- prior tuberculosis
- HIV infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre antituberculeux; Geneva University Hospital
Geneva, Geneva 14, 1211
About this study
Official title: Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and 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.
Read the 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.
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, interferon gamma release assays, treatment
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startOct 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Investigators
- Jean-Paul Janssens, M.D., Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595907
- Sponsor's protocol ID
- Janssens1/2008
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17537773Bosshard 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.
PubMed 18977647
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Production of IFN-Gamma by Peripheral Lymphocytes in Response to Specific Antigens Before and After Treatment for Tuberculosis
- ClinicalTrials.gov ID
- NCT00595907
- Acronym / sponsor ID
- Janssens1/2008
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, interferon gamma release assays, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Study start
- Oct 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients either at diagnosis of tuberculosis, under treatment for tuberculosis, or within 6 months after treatment completion
Key inclusion criteria (1 listed)
- culture proven tuberculosis
Key exclusion criteria (3 listed)
- age < 18
- prior tuberculosis
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
- Background: PubMed 17537773Janssens 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.
- Derived from this study: PubMed 18977647Bosshard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Janssens, M.D. principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interferon gamma response to M. tuberculosis antigens by peripheral lymphocytes after treatment for tuberculosis (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00595907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008.