Cohort study on tuberculosis in children in Italy
Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 1 Week to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 17 sites (Florence, Firenze and 16 other locations) |
| Trial ID | NCT06289660 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 0-18 years with active or latent tuberculosis or those exposed to TB.
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.
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 performed: Other studies have highlighted the need for better data on pediatric tuberculosis, but this specific cohort approach is relatively novel.
Eligibility criteria
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 this trial is running
Florence, Firenze and 16 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.