Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
1 other identifier
observational
1,000
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2022
CompletedFirst Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
March 4, 2024
February 1, 2024
10 years
February 15, 2024
February 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Epidemiology of Tuberculosis
Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.
Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months
Eligibility Criteria
During the study, data will be collected on patients affected by active TB, latent TB, and TB-exposed non-infected individuals from each participating center. The study will take place at the main pediatric centers in Italy that consecutively admit patients diagnosed with active and latent TB, as well as individuals exposed to tuberculosis who are seen at participating clinical centers.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Meyer Children's Hospital IRCCS
Florence, Firenze, 50139, Italy
Ospedale Pediatrico Giovanni XXIII
Bari, Italy
Ospedale di Belluno
Belluno, Italy
Università di Bologna
Bologna, Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico
Milan, Italy
Ospedale Luigi Sacco
Milan, Italy
Policlinico di Modena
Modena, Italy
Università Federico II
Napoli, Italy
Ospedale dei Bambini "G.Di Cristina"
Palermo, Italy
Ospedale di Parma
Parma, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Azienda USL Toscana Centro
Prato, Italy
IRCCS Ospedale Pediatrico Bambin Gesù
Roma, Italy
Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Ospedale Regina Margherita
Torino, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 15, 2024
First Posted
March 4, 2024
Study Start
December 22, 2022
Primary Completion (Estimated)
January 2, 2033
Study Completion (Estimated)
March 1, 2033
Last Updated
March 4, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share