Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
ConditionTuberculosis Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorMeyer Children's Hospital IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Epidemiology of Tuberculosis
Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.
Time frame
Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 monthsSponsors and contacts
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Source ClinicalTrials.gov