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Recruiting NCT06289660

Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Observational Tuberculosis Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tuberculosis Infection. Basic parameters: 1 Week — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age

Overview

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.

Primary outcome measures

  • Epidemiology of Tuberculosis [Time frame: Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 17 centers
  • Meyer Children's Hospital IRCCS — Florence
  • Ospedale Pediatrico Giovanni XXIII — Bari
  • Ospedale di Belluno — Belluno
  • Università di Bologna — Bologna
  • IRCCS Istituto Giannina Gaslini — Genova
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico — Milan
  • Ospedale Luigi Sacco — Milan
  • Policlinico di Modena — Modena
  • … and 9 more centers

Identifiers

NCT: NCT06289660 · PED-TB22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗