Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Last updated: February 29, 2024
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT06289660
PED-TB22
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 WorldHealth Organization
  • Patients exposed to TB who are found to be non-infected at the end of the windowperiod
  • Informed consent signed by parents/legal guardian or by the patient who has reachedthe legal age of consent, assent of the minor

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 1000
Study Start date:
December 22, 2022
Estimated Completion Date:
March 01, 2033

Study 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.

Connect with a study center

  • Meyer Children's Hospital IRCCS

    Florence, Firenze 50139
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Giovanni XXIII

    Bari,
    Italy

    Active - Recruiting

  • Ospedale di Belluno

    Belluno,
    Italy

    Active - Recruiting

  • Università di Bologna

    Bologna,
    Italy

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genova,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Luigi Sacco

    Milano,
    Italy

    Active - Recruiting

  • Policlinico di Modena

    Modena,
    Italy

    Active - Recruiting

  • Università Federico II

    Napoli,
    Italy

    Active - Recruiting

  • Ospedale dei Bambini "G.Di Cristina"

    Palermo,
    Italy

    Active - Recruiting

  • Ospedale di Parma

    Parma,
    Italy

    Active - Recruiting

  • IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Active - Recruiting

  • Azienda USL Toscana Centro

    Prato,
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambin Gesù

    Roma,
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli IRCCS

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Regina Margherita

    Torino,
    Italy

    Active - Recruiting

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