Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Recruiting

• Conditions: Tuberculosis Infection

• Registration Number: NCT06289660
• Lead Sponsor: Meyer Children's Hospital IRCCS

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.

Detailed Description

In recent decades, Tuberculosis (TB) has been considered, in industrialized countries, as predominantly an infectious disease of the elderly. However, since the 2000s, TB has re-emerged not only in the elderly but also in the young and especially in pediatric populations. Among the factors influencing the increase in the incidence of this pathology are certainly to be considered the rise in immigration from countries with high endemicity, where TB still represents a significant cause of morbidity and mortality, the spread of immunodeficiency caused by HIV infection, the use of immunosuppressive drugs, and the emergence of strains of M. tuberculosis resistant to traditional antibiotic therapy.

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 TB in pediatric age are extremely limited due to diagnostic difficulties in this patient category. In children, in fact, bacteriological examination is negative in 95% of cases, and the diagnosis is made through a combination of clinical criteria and tests that are poorly specific for tuberculous infection and especially not universally accepted. In addition to diagnostic controversies, 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 this condition may be significantly underestimated both in Italy and worldwide.

Another important aspect to consider is that tuberculous disease, whether active or latent, in a child should be considered a sentinel event that indicates recent transmission of M. tuberculosis within the community. Especially in the pediatric population, in addition to the mandatory reporting of confirmed cases of TB disease, it is important to identify cases of latent TB through historical and diagnostic criteria. Children indeed have a greater likelihood that the disease will progress to the active form compared to adults and that the progression will be towards a more severe form. Children with latent tuberculous infection also become a reservoir for the transmission of the infection, fueling future epidemics.

Study Timeline

• Study Start: 2022-12-22
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2033-01-02
• Study Completion: 2033-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiology of Tuberculosis	Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months	Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.

Trial Locations

Locations (17)

IRCCS Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Università di Bologna; 🇮🇹 Bologna, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Firenze, Italy

Ospedale Pediatrico Giovanni XXIII; 🇮🇹 Bari, Italy

Ospedale di Belluno; 🇮🇹 Belluno, Italy

Ospedale Luigi Sacco; 🇮🇹 Milano, Italy

Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico; 🇮🇹 Milano, Italy

Policlinico di Modena; 🇮🇹 Modena, Italy

Ospedale di Parma; 🇮🇹 Parma, Italy

Università Federico II; 🇮🇹 Napoli, Italy

Ospedale dei Bambini "G.Di Cristina"; 🇮🇹 Palermo, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda USL Toscana Centro; 🇮🇹 Prato, Italy

Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy

IRCCS Ospedale Pediatrico Bambin Gesù; 🇮🇹 Roma, Italy

Ospedale Regina Margherita; 🇮🇹 Torino, Italy