Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
NCT ID: NCT06289660
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-12-22
2033-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
1 Week
18 Years
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Luisa Galli
Clinical Professor
Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PED-TB22
Identifier Type: -
Identifier Source: org_study_id
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