Latent Tuberculosis InfectionNCT01608685
Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients
An observational study of Latent Tuberculosis Infection, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
Trial summary
Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis Infection
- How many people
- 205 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2011
- 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 followed by the Division of Nephrology after renal transplantation, and undergoing routine annual check-ups, in stable clinical condition, aged above 18
Who may be able to join
- prior renal transplantation;
- age > 18;
- stable clinical condition
Who cannot join
- hypersensitivity to tuberculin skin testing
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital/Division of Nephrology
Geneva, Canton of Geneva, 1211
About this study
Official title: Interferon Gamma Release Assays Versus Tuberculin Skin Testing for the Detection of Latent Tuberculosis Infection in Renal Transplant Recipients
Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV.
The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.
Read the detailed description
In a recent study (Triverio PA et al. "Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in haemodialysis patients". Nephrol Dial Transplant 2009; 24: 1952-6), the investigators had compared 2 IGRAs (T-SPOT.TB and Quantiferon Gold) with the TST and shown that one IGRA was clearly more sensitive than the TST but that both tests had a very low sensitivity for detecting prior TB.
This study applies the same protocol to renal transplant recipients undergoing routine annual check-up visits: questionnaire with detailed collection of risk factors for latent tuberculosis infection (LTBI), history of prior contact with tuberculosis (TB), BCG (Bacille of Calmette and Guerin vaccine), prior TB or LTBI, treatment for TB or LTBI, analysis of chest X-ray for signs of prior TB, on-going treatment, level of immunosuppression (CD4 lymphocytes), simultaneous blood sampling for T-SPOT.TB and Quantiferon Gold, and tuberculin skin testing.
- Conditions
- Latent Tuberculosis Infection
- Keywords
- Tuberculosis, Latent tuberculosis infection, Immunosuppression, Renal transplant recipient
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant recipients | Inclusion criteria: All renal transplant recipients followed by the Division of Nephrology aged above 18 years, and having accepted study protocol after informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection
Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and results of QuantiFERON-Gold-in-tube is computed
Measured: Up to 3 years
Agreement between results of T-SPOT.TB and probability of latent tuberculosis infection
Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and result of T-SPOT.TB is computed
Measured: Up to 3 years
Secondary outcomes (1)
Agreement between results of IGRA tests and TST in renal transplant recipients
Agreement between results of IGRA testing and between each IGRA test and TST will be determined by computing kappa values
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Genevoise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Janssens, Ligue Pulmonaire Genevoise
- Investigators
- Karin Hadaya, MD, Principal investigator, Division of Nephrology/Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608685
- Sponsor's protocol ID
- KH-2010
- Status last verified
- May 2012
- First submitted
- 5 Jul 2011
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Triverio PA, Bridevaux PO, Roux-Lombard P, Niksic L, Rochat T, Martin PY, Saudan P, Janssens JP. Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in chronic haemodialysis patients. Nephrol Dial Transplant. 2009 Jun;24(6):1952-6. doi: 10.1093/ndt/gfn748. Epub 2009 Jan 22.
PubMed 19164327Hadaya K, Bridevaux PO, Roux-Lombard P, Delort A, Saudan P, Martin PY, Janssens JP. Contribution of interferon-gamma release assays (IGRAs) to the diagnosis of latent tuberculosis infection after renal transplantation. Transplantation. 2013 Jun 27;95(12):1485-90. doi: 10.1097/TP.0b013e3182907073.
PubMed 23694948
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Gamma Release Assays Versus Tuberculin Skin Testing for the Detection of Latent Tuberculosis Infection in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01608685
- Acronym / sponsor ID
- KH-2010
- Conditions
- Latent Tuberculosis Infection
- Keywords
- Tuberculosis, Latent tuberculosis infection, Immunosuppression, Renal transplant recipient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Ligue Pulmonaire GenevoiseUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 May 2012 (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.
Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV.
The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.
Detailed description
In a recent study (Triverio PA et al. "Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in haemodialysis patients". Nephrol Dial Transplant 2009; 24: 1952-6), the investigators had compared 2 IGRAs (T-SPOT.TB and Quantiferon Gold) with the TST and shown that one IGRA was clearly more sensitive than the TST but that both tests had a very low sensitivity for detecting prior TB.
This study applies the same protocol to renal transplant recipients undergoing routine annual check-up visits: questionnaire with detailed collection of risk factors for latent tuberculosis infection (LTBI), history of prior contact with tuberculosis (TB), BCG (Bacille of Calmette and Guerin vaccine), prior TB or LTBI, treatment for TB or LTBI, analysis of chest X-ray for signs of prior TB, on-going treatment, level of immunosuppression (CD4 lymphocytes), simultaneous blood sampling for T-SPOT.TB and Quantiferon Gold, and tuberculin skin testing.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal transplant recipients | – | –Inclusion criteria: All renal transplant recipients followed by the Division of Nephrology aged above 18 years, and having accepted study protocol after informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed by the Division of Nephrology after renal transplantation, and undergoing routine annual check-ups, in stable clinical condition, aged above 18
Key inclusion criteria (3 listed)
- prior renal transplantation;
- age > 18;
- stable clinical condition
Key exclusion criteria (1 listed)
- hypersensitivity to tuberculin skin testing
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
Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection
Time frame: Up to 3 years
Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and results of QuantiFERON-Gold-in-tube is computed
Agreement between results of T-SPOT.TB and probability of latent tuberculosis infection
Time frame: Up to 3 years
Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and result of T-SPOT.TB is computed
1 secondary outcome
Agreement between results of IGRA tests and TST in renal transplant recipients
Time frame: Up to 3 years
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 31 May 2012.
- Background: PubMed 19164327Triverio PA, Bridevaux PO, Roux-Lombard P, Niksic L, Rochat T, Martin PY, Saudan P, Janssens JP. Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in chronic haemodialysis patients. Nephrol Dial Transplant. 2009 Jun;24(6):1952-6. doi: 10.1093/ndt/gfn748. Epub 2009 Jan 22.
- Derived from this study: PubMed 23694948Hadaya K, Bridevaux PO, Roux-Lombard P, Delort A, Saudan P, Martin PY, Janssens JP. Contribution of interferon-gamma release assays (IGRAs) to the diagnosis of latent tuberculosis infection after renal transplantation. Transplantation. 2013 Jun 27;95(12):1485-90. doi: 10.1097/TP.0b013e3182907073.
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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.
Karin Hadaya, MD principal investigator
Division of Nephrology/Geneva University Hospital
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 Latent Tuberculosis Infection, run by Ligue Pulmonaire Genevoise 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 3 inclusion and 1 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 31 May 2012. 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?
Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 NCT01608685, 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 31 May 2012.