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IGRA and Mantoux Response in Children With Suspected Latent or Active TB Infection

NCT02653404 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Tuberculosis, Pulmonary
  • Interferon-gamma Release Tests
  • Tuberculin Test

Interventions

OTHER

IGRA test (QTF-GIT)

blood sample for QFT-GIT will be taken together with other routine blood samples

Sponsors & Collaborators

  • University of Siena

    lead OTHER

Principal Investigators

  • Francesca Montagnani, PhD, MD · Università di Siena - Azienda Ospedaliera Santa Maria alle Scotte

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-04-30
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653404 on ClinicalTrials.gov