Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289660
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-15
Brief Title:
Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
Sponsor:
Meyer Childrens Hospital IRCCS
Organization:
Meyer Childrens Hospital IRCCS
Study Overview
Official Title:
Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None