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Clinical Trials in Italy / NCT06289660
Recruiting Observational

Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

NCT06289660 · tracked via the Priya Life Science Italy tracker
Sponsor
Meyer Children's Hospital IRCCS
Phase
Observational
Started
2022-12-22
Last updated
2024-03-04

Condition(s) studied

Tuberculosis Infection

Study summary

According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide.

Eligibility

Sex
ALL
Min age
1 Week
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Pediatric patients (0-18 years old) at the time of the initial observation * Patients affected by active and latent TB, as defined by the criteria of the World Health Organization * Patients exposed to TB who are found to be non-infected at the end of the window period * Informed consent signed by parents/legal guardian or by the patient who has reached the legal age of consent, assent of the minor Exclusion Criteria: * None

Primary outcome measure(s)

  • Epidemiology of Tuberculosis — Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months
    Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.

Trial sites (17)

FacilityCityRegionStatus
Meyer Children's Hospital IRCCS Florence Firenze Recruiting
Ospedale Pediatrico Giovanni XXIII Bari Italy Recruiting
Ospedale di Belluno Belluno Italy Recruiting
Università di Bologna Bologna Italy Recruiting
IRCCS Istituto Giannina Gaslini Genova Italy Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico Milan Italy Recruiting
Ospedale Luigi Sacco Milan Italy Recruiting
Policlinico di Modena Modena Italy Recruiting
Università Federico II Naples Italy Recruiting
Ospedale dei Bambini "G.Di Cristina" Palermo Italy Recruiting
Ospedale di Parma Parma Italy Recruiting
IRCCS Policlinico San Matteo Pavia Italy Recruiting
Azienda Ospedaliero Universitaria Pisana Pisa Italy Recruiting
Azienda USL Toscana Centro Prato Italy Recruiting
IRCCS Ospedale Pediatrico Bambin Gesù Roma Italy Recruiting
Policlinico Universitario Agostino Gemelli IRCCS Roma Italy Recruiting
Ospedale Regina Margherita Torino Italy Recruiting

More Meyer Children's Hospital IRCCS trials in Italy

Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population Recruiting
Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis Recruiting
SLIT ABS: Study on Patients With Autoimmune Podocytopathy Recruiting
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age. Recruiting
Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes Recruiting

Other trials for the same condition

Isoniazid-Related Hepatotoxicity in Clinical Practice: Incidence and Predictors Starting soon
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06289660 on ClinicalTrials.gov ↗ ← All trials in Italy