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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00707317




Registration number
NCT00707317
Ethics application status
Date submitted
25/06/2008
Date registered
30/06/2008
Date last updated
16/12/2015

Titles & IDs
Public title
T Cell Interferon-gamma Release Assay (TIGRA) in Immunocompromised Individuals
Scientific title
Prospective Head-to-head Comparison of the Two Commercially Available Approved TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) With the Established Mendel-Mantoux Skin-test in Immunocompromized Patients
Secondary ID [1] 0 0
TBNET-TIGRA
Universal Trial Number (UTN)
Trial acronym
TBNET-TIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 0 0
Monitoring, Immunologic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - HIV infected individuals

2 - patients with chronic renal failure

3 - patients after solid organ transplantation (lung, liver, kidney, kidney-pancreas)

4 - patients with rheumatoid arthritis

5 - stem cell transplant recipients

6 - immunocompromised patients with confirmed tuberculosis

7 - immunocompetent controls with no known risk of exposure or tuberculosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IGRA performance
Timepoint [1] 0 0
at the time of analysis
Secondary outcome [1] 0 0
active tuberculosis on follow-up
Timepoint [1] 0 0
variable follow-up on all patients

Eligibility
Key inclusion criteria
- Individual as specified for the study population

- Written informed consent

- Indication to perform tuberculin skin test(suspect latent infection, according to
standard guidelines, differential diagnosis)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- <18 years of age

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
1843
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cellestis Limited - Carnegie
Recruitment postcode(s) [1] 0 0
- Carnegie
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Denmark
State/province [2] 0 0
Herlev
Country [3] 0 0
Germany
State/province [3] 0 0
Borstel
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Freiburg
Country [6] 0 0
Germany
State/province [6] 0 0
Homburg
Country [7] 0 0
Greece
State/province [7] 0 0
Mezourlo-Larissa
Country [8] 0 0
Italy
State/province [8] 0 0
Milan
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Italy
State/province [10] 0 0
Tradate
Country [11] 0 0
Netherlands
State/province [11] 0 0
The Hague
Country [12] 0 0
Portugal
State/province [12] 0 0
Lisbon
Country [13] 0 0
Romania
State/province [13] 0 0
Bucharest
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Switzerland
State/province [16] 0 0
Geneva
Country [17] 0 0
Turkey
State/province [17] 0 0
Ankara
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Tuberculosis Network European Trialsgroup
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for
detection of latent infection with M. tuberculosis (LTBI). Despite the low overall incidence
of symptomatic tuberculosis infection in low-prevalence countries, the potential mortality
and morbidity mandate constant vigilance to identify patients at risk for reactivation. Due
to systemic immunosuppression, immunocompromised patients with latent M. tuberculosis
infection are at increased risk of progression to active disease. This applies to patients
with various causes of immunodeficiency such as HIV-infected patients, allogeneic stem cell
and solid organ transplant recipients, patients with rheumatoid arthritis and patients with
chronic renal failure. Therefore, current guidelines aimed at preventing tuberculosis
infection in immunocompromized individuals recommend a generalized screening for evidence of
latent infection to target appropriate preventative prophylaxis. At present, tuberculosis
control programs exclusively rely on the tuberculin skin test to identify a latent infection
in asymptomatic individuals.

Recently, novel in vitro assays termed T cell interferon-gamma release assay (TIGRA) have
become available that are based on the detection of interferon-gamma (IFN-gamma) production
in T cells or supernatants after stimulation with highly specific antigens of M.
tuberculosis. Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA
based QuantiFERON-TB Gold test (now available as an "IN-TUBE" version).

The aim of the study is a prospective comparison of the two commercially available approved
TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) with the established Mendel-Mantoux
skin-test in immunocompromized patients (main focus on sensitivity and specificity).

The study hypotheses are as follows:

1. In immunocompromised patients, the two commercially available approved TIGRA
(QuantiFERON-TB Gold In-Tube and T.SPOT.TB) have increased sensitivity and specificity
as compared to the established Mendel-Mantoux skin-test.

2. Results from QuantiFERON-TB Gold In-Tube and T.SPOT.TB do not differ in
immunocompromised patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00707317
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martina Sester, PhD
Address 0 0
Department of Transplant and Infection Immunology, University of the Saarland, 66421 Homburg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00707317