Clinical trial Recruiting at 17 sites Observational Ages 1 Week to 18

Cohort study on tuberculosis in children in Italy

Official title: Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age

Run by Meyer Children's Hospital IRCCS · NCT06289660 · Data updated 2026-11-12

This study is trying to gather information about tuberculosis in children in Italy to better understand and manage the disease in young patients.

Quick facts

Study typeObservational
Ages1 Week to 18 Years
SexAll
Enrollment1000 (estimated)
SponsorMeyer Children's Hospital IRCCS
Academic / other
Locations17 sites (Florence, Firenze and 16 other locations)
StatusRecruiting
StartedDecember 22, 2022
Main results expectedJanuary 2, 2033
Study endsMarch 1, 2033
Registry record updatedMarch 4, 2024
Trial IDNCT06289660 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pediatric patients aged 0-18 years with active or latent tuberculosis or those exposed to TB.

Probably not a fit

Patients who are not within the pediatric age range or those without any exposure to tuberculosis may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather epidemiological data on tuberculosis (TB) in the pediatric population across multiple centers in Italy. It focuses on children aged 0-18 years who are affected by active or latent TB, as well as those exposed to TB but found to be non-infected. The study addresses the significant underreporting of TB cases in children due to diagnostic challenges and the lack of integration between pediatric healthcare providers and national surveillance systems. By collecting and analyzing data, the study seeks to improve understanding and management of TB in this vulnerable population.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis, treatment, and prevention strategies for tuberculosis in children.

How similar studies have gone: Other studies have highlighted the need for better data on pediatric tuberculosis, but this specific cohort approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Meyer Children's Hospital IRCCS
    Florence, Firenze, Italy
    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
Show 11 more locations
  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.