IGRA and Mantoux Response in Children With Suspected Latent or Active TB Infection
Sponsored by University of Siena
About this trial
Last updated 8 years ago
Study ID
IGRAManPed2014
Status
Unknown status
Type
Observational
Placebo
No
Accepting
1 to 17 Years
All
Trial Timing
Ended 5 years ago
What is this trial about?
The aim of this project is to analyze the potential contribution of IGRA test QuantiFERON-TB
Gold In Tube test (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in the
diagnosis of tuberculosis (TB - active or latent) in pediatric subjects (0 and 17 year)s
recently exposed to infection (indicated as "contacts") or with clinical suspicion of active
TB, and to compare the results obtained with those of the TuberculinSkin Test (TST; gold
standard). The project is expected to enroll up to 50 pediatric patients over a 4-year study.
Children with access to Ambulatory structures or hospitalized at University Infectious
Diseases Clinic or Pediatric Clinic, University Hospital of Siena, or with access to
Ambulatory or hospitalized at Pediatric Clinic USL 9 Grosseto will be enrolled. Once obtained
the informed consent of patients' parents or legal guardians, patients will be enrolled. The
doctor will administer a clinical-anamnestic questionnaire, relative to the country of birth
and residence, date of arrival in Italy and any stays in the country of origin (in case of
foreign patient), travels abroad, risk factors for infectious diseases, type of contact with
any index case, previous vaccination with BCG, date and outcome of the TST, clinical symptoms
and signs suggestive of active TB, report of any instrumental investigation. Together with
the collection of blood samples for routine purposes, an additional blood sample will be
taken so to run IGRA test. Also patients for whom their medical doctor will independently
order to run QTF-GIT test as necessary tool for the clinical diagnosis of TB will be included
in the study.
A retrospective analysis will be performed on patient pertaining to participant Clinics, from
1 January 2012 to 31 May 2015. Such analysis will be performed on those patients for which
their medical doctor requested both intradermal Mantoux and IGRA test.
Expected results:
- estimation of concordance between QuantiFERON-TB Gold In Tube and TST in pediatric
patients exposed to TB, with or without latent TB infection
- Evaluation of the sensitivity of the test QTF-GIT in patients with active tuberculosis
disease
- Evaluation of specificity of testQTF-GIT in not infected patients
- Evaluation on the possible use of QTF-GIT, together with TST, to improve the diagnosis
of tuberculosis latent or active infection in pediatric subjects.
- Evaluation of the possible diagnostic use of QTF-GIT in the child <5 years.
What are the participation requirements?
Inclusion Criteria
- Age between 0 to 17 years
- Willingness to provide informed consent (parents or legal guardians)
- Contact with TB case and/or clinical suspect of active TB
Exclusion Criteria
- Acquired or congenital immune deficiencies
- Oncohematologic diseases