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 type | Observational |
|---|---|
| Ages | 1 Week to 18 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 17 sites (Florence, Firenze and 16 other locations) |
| Status | Recruiting |
| Started | December 22, 2022 |
| Main results expected | January 2, 2033 |
| Study ends | March 1, 2033 |
| Registry record updated | March 4, 2024 |
| Trial ID | NCT06289660 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
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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
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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
- Study coordinator: Luisa Galli, MD
- Email: luisa.galli@meyer.it
- Phone: +390555662439
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.