Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06289660 |
| Other study ID # |
PED-TB22 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 22, 2022 |
| Est. completion date |
March 1, 2033 |
Study information
| Verified date |
February 2024 |
| Source |
Meyer Children's Hospital IRCCS |
| Contact |
Luisa Galli, MD |
| Phone |
+390555662439 |
| Email |
luisa.galli[@]meyer.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
