TBnet#54: New Generation IGRA in Immunocompromised Individuals

Sponsor

Tuberculosis Network European Trialsgroup (Other)

Overall Status

Unknown status

CT.gov ID

NCT02639936

Collaborator

(none)

2,000

Enrollment

Locations

Duration (Months)

125

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients

Condition or Disease	Intervention/Treatment	Phase
Monitoring, Immunologic Active Tuberculosis Tuberculosis in Solid Organ Transplant Recipients Tuberculosis in Marrow Transplant Recipients Tuberculosis in Rheumatoid Arthritis Tuberculosis in Chronic Renal Failure Tuberculosis in HIV-infected Individuals

Detailed Description

This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Performance of a New Generation IGRA in Immunocompromised Individuals

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Immunocompetent controls Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
Solid organ transplant recipients Patients after solid organ transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
Stem cell transplant recipients Patients after stem cell transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
Patients with rheumatoid arthritis Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
Patients with chronic renal failure Patients with chronic renal failure with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
Individuals with HIV infection Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis

Outcome Measures

Primary Outcome Measures

Specificity [2 years]
The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.
Sensitivity [2 years]
The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
Indeterminate results [2 years]
The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
Association with exposure [2 years]
Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
Progression [4 years]
The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Individuals as specified for the study Population
Written informed consent

Exclusion Criteria:

<18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Kopenhagen		Denmark	2100
2	Research center Borstel	Borstel		Germany
3	Freiburg University	Freiburg		Germany	79100
4	Saarland University	Homburg		Germany	66421
5	University of Brescia and Brescia Spedali Civili General Hospital	Brescia		Italy
6	San Raffaele Scientific institute	Milano		Italy	20132
7	National Institute for Infectious Diseases L. Spallanzani	Rome		Italy	00149
8	Department of Pneumology & Allergology	Chisinau		Moldova, Republic of	2004
9	Department of Infectious Diseases; Oslo University	Oslo		Norway	0450
10	Warszawski Uniwersytet Medyczny	Warszawa		Poland	02-097
11	Centro de Diagnóstico Pneumológico	Vila Nova de Gaia		Portugal
12	Marius Nasta Institute of Pneumology	Bucharest	Sector 5	Romania	5
13	Institut d'Investigació Germans Trias i Pujol	Badalona		Spain	08916
14	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08001
15	Hospital Universitario Central de Asturias	Oviedo		Spain	33001
16	Department of Respiratory Medicine, Royal Free Hospital	London		United Kingdom	NW3 2QG

Sponsors and Collaborators

Tuberculosis Network European Trialsgroup

Investigators

Principal Investigator: Martina Sester, PhD, Universität des Saarlandes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tuberculosis Network European Trialsgroup

ClinicalTrials.gov Identifier:

NCT02639936

Other Study ID Numbers:

TBnet study #54

First Posted:

Dec 28, 2015

Last Update Posted:

Aug 9, 2016

Last Verified:

Aug 1, 2016

Additional relevant MeSH terms:

Tuberculosis

Kidney Failure, Chronic

Study Results

No Results Posted as of Aug 9, 2016