RecruitingNCT06289660

Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

1,000 participants

Start Date

Dec 22, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 WeekMax Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • None

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Locations(17)

Meyer Children's Hospital IRCCS

Florence, Firenze, Italy

Ospedale Pediatrico Giovanni XXIII

Bari, Italy

Ospedale di Belluno

Belluno, Italy

Università di Bologna

Bologna, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico

Milan, Italy

Ospedale Luigi Sacco

Milan, Italy

Policlinico di Modena

Modena, Italy

Università Federico II

Naples, Italy

Ospedale dei Bambini "G.Di Cristina"

Palermo, Italy

Ospedale di Parma

Parma, Italy

IRCCS Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda USL Toscana Centro

Prato, Italy

IRCCS Ospedale Pediatrico Bambin Gesù

Roma, Italy

Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Ospedale Regina Margherita

Torino, Italy

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NCT06289660


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