Clinical trial NCT06289660: Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
Official title: Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis Infection
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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

Primary outcomes:
measure: Epidemiology of Tuberculosis
timeFrame: Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
state: Firenze
city: Bari
country: Italy
facility: Ospedale Pediatrico Giovanni XXIII
city: Belluno
country: Italy
facility: Ospedale di Belluno
city: Bologna
country: Italy
facility: Università di Bologna
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Modena
country: Italy
facility: Policlinico di Modena
city: Napoli
country: Italy
facility: Università Federico II
city: Palermo
country: Italy
facility: Ospedale dei Bambini "G.Di Cristina"
city: Parma
country: Italy
facility: Ospedale di Parma
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Prato
country: Italy
facility: Azienda USL Toscana Centro
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambin Gesù
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli IRCCS
city: Torino
country: Italy
facility: Ospedale Regina Margherita
Study officials:
References: