Actively Recruiting

Age: 1Week - 18Years
All Genders
ID06289660

Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age

Led by Meyer Children's Hospital IRCCS · Updated on 2024-03-04

1000

Participants Needed

17

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tuberculosis (TB) is increasingly affecting children and young people, not just the elderly, especially in industrialized countries. Factors such as immigration from high TB areas, HIV-induced immunodeficiency, immunosuppressive drugs, and resistant TB strains contribute to its rise. The available data on TB in children is scarce due to diagnostic challenges and poor integration with national surveillance systems, suggesting the disease may be underreported both in Italy and worldwide. This observational study follows pediatric patients from 0 to 18 years old who have active or latent TB or have been exposed without infection. The study collects information on these patients over an average treatment period of 6 months and evaluates outcomes at 24 months, focusing on the epidemiology of TB in this age group. The research aims to improve understanding of TB transmission and progression in children. Participants undergo regular clinical observations and assessments according to World Health Organization criteria, with data collected from initial observation through treatment completion and follow-up. The study monitors disease progression, infection status, and outcomes, helping identify latent TB cases and supporting better surveillance. Total participation varies but includes baseline and long-term follow-up over 24 months.

CONDITIONS

Brief Title

Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Who Can Participate

Age: 1Week - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 24 months

Participants are observed over time to collect epidemiological data on tuberculosis in pediatric patients.

Regular visits during an average of 6 months with outcome assessment at 24 months

Trial Site Locations

Total: 17 locations

1

Meyer Children's Hospital IRCCS

Florence, Firenze, Italy, 50139

Actively Recruiting

2

Ospedale Pediatrico Giovanni XXIII

Bari, Italy

Actively Recruiting

3

Ospedale di Belluno

Belluno, Italy

Actively Recruiting

4

Università di Bologna

Bologna, Italy

Actively Recruiting

5

IRCCS Istituto Giannina Gaslini

Genova, Italy

Actively Recruiting

6

Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico

Milan, Italy

Actively Recruiting

7

Ospedale Luigi Sacco

Milan, Italy

Actively Recruiting

8

Policlinico di Modena

Modena, Italy

Actively Recruiting

9

Università Federico II

Naples, Italy

Actively Recruiting

10

Ospedale dei Bambini "G.Di Cristina"

Palermo, Italy

Actively Recruiting

11

Ospedale di Parma

Parma, Italy

Actively Recruiting

12

IRCCS Policlinico San Matteo

Pavia, Italy

Actively Recruiting

13

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Actively Recruiting

14

Azienda USL Toscana Centro

Prato, Italy

Actively Recruiting

15

IRCCS Ospedale Pediatrico Bambin Gesù

Roma, Italy

Actively Recruiting

16

Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Actively Recruiting

17

Ospedale Regina Margherita

Torino, Italy

Actively Recruiting

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Research Team

L

Luisa Galli, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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