Tuberculosis, Pulmonary Clinical Trial
— TBTubercolarOfficial title:
Observational Study to Compare IGRA and Mantoux Test in Children With Suspected Latent or Active TB Infection
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2020 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | UOC Pediatria, USL9, Grosseto | Grosseto | GR |
Italy | UOC Malattie Infettive Universitarie c/o Policlinico Le Scotte, Viale Mario Bracci 16 | Siena | |
Italy | UOC Pediatria c/o Policlinico Le Scotte, Viale Mario Bracci 16 | Siena | SI |
Lead Sponsor | Collaborator |
---|---|
University of Siena |
Italy,
Andersen P, Munk ME, Pollock JM, Doherty TM. Specific immune-based diagnosis of tuberculosis. Lancet. 2000 Sep 23;356(9235):1099-104. Review. — View Citation
Blandinières A, de Lauzanne A, Guérin-El Khourouj V, Gourgouillon N, See H, Pédron B, Faye A, Sterkers G. QuantiFERON to diagnose infection by Mycobacterium tuberculosis: performance in infants and older children. J Infect. 2013 Nov;67(5):391-8. doi: 10.1 — View Citation
Chiappini E, Accetta G, Bonsignori F, Boddi V, Galli L, Biggeri A, De Martino M. Interferon-? release assays for the diagnosis of Mycobacterium tuberculosis infection in children: a systematic review and meta-analysis. Int J Immunopathol Pharmacol. 2012 J — View Citation
Diel R, Goletti D, Ferrara G, Bothamley G, Cirillo D, Kampmann B, Lange C, Losi M, Markova R, Migliori GB, Nienhaus A, Ruhwald M, Wagner D, Zellweger JP, Huitric E, Sandgren A, Manissero D. Interferon-? release assays for the diagnosis of latent Mycobacte — View Citation
Huebner RE, Schein MF, Bass JB Jr. The tuberculin skin test. Clin Infect Dis. 1993 Dec;17(6):968-75. Review. — View Citation
Marais BJ, Gie RP, Schaaf HS, Hesseling AC, Obihara CC, Starke JJ, Enarson DA, Donald PR, Beyers N. The natural history of childhood intra-thoracic tuberculosis: a critical review of literature from the pre-chemotherapy era. Int J Tuberc Lung Dis. 2004 Ap — View Citation
Muñoz L, Santin M. Interferon-? release assays versus tuberculin skin test for targeting people for tuberculosis preventive treatment: an evidence-based review. J Infect. 2013 Apr;66(4):381-7. doi: 10.1016/j.jinf.2012.12.005. Epub 2013 Jan 5. Review. — View Citation
Sollai S, Galli L, de Martino M, Chiappini E. Systematic review and meta-analysis on the utility of Interferon-gamma release assays for the diagnosis of Mycobacterium tuberculosis infection in children: a 2013 update. BMC Infect Dis. 2014;14 Suppl 1:S6. d — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with concordance of QTF-GIT test and TST,among children exposed to TB | up to 4 years | ||
Primary | Number of patients with positivity of QTF-GIT in comparison with TST among children with active tuberculosis disease | up to 4 years | ||
Primary | Number of patients with a negative QTF-GIT test in comparison of TST, among non-infected children | up to 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06084715 -
The INSTITUT Study
|
||
Terminated |
NCT03028129 -
Prevention of Tuberculosis in Prisons
|
Phase 4 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Withdrawn |
NCT03862248 -
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
|
Phase 3 | |
Completed |
NCT03271567 -
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Active, not recruiting |
NCT04919239 -
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
|
Phase 2 | |
Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
Recruiting |
NCT05926466 -
BTZ-043 Dose Evaluation in Combination and Selection
|
Phase 2 | |
Recruiting |
NCT04752592 -
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Not yet recruiting |
NCT04968886 -
TuBerculosis Viability Interregional Study and Agreement on Biological Tests
|
||
Not yet recruiting |
NCT04485156 -
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
|
Phase 3 | |
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT01364324 -
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
|
||
Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
Completed |
NCT05899400 -
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
|
||
Completed |
NCT04938596 -
Airborne Preventive Measures to Reduce New TB Infections in Household Contacts
|
N/A | |
Recruiting |
NCT05455112 -
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
|
Phase 2 | |
Completed |
NCT03044158 -
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
|
N/A |