Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here