Tuberculosis InfectionNCT06289660
Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age
An observational study of Tuberculosis Infection, run by Meyer Children's Hospital IRCCS at 17 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 week to 18 years
- Conditions the study is for
- Tuberculosis Infection
- How many people
- 1,000 participants
- Where
- 17 sitesItaly
- Study dates
- 22 Dec 2022to 1 Mar 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Italy17 sites, 17 recruiting
- Recruiting
Ospedale Pediatrico Giovanni XXIII
Bari
Desiree Caselli, desiree.caselli@policlinico.ba.it
- Recruiting
Ospedale di Belluno
Belluno
Giangiacomo Nicolini, gnicolini@gmail.com
- Recruiting
Università di Bologna
Bologna
Marcello Lanari, marcello.lanari@unibo.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Firenze, 50139
Luisa Galli, luisa.galli@meyer.it
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova
Elio Castagnola, eliocastagnola@gaslini.org
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico
Milan
Samantha Bosis, MD, samantha.bosis@policlinico.mi.it
- Recruiting
Ospedale Luigi Sacco
Milan
Vania Giacomet, vania.giacomet@unimi.it
- Recruiting
Policlinico di Modena
Modena
Barbara Maria Bergamini, bergamini.barbaramaria@unimo.it
- Recruiting
Università Federico II
Naples
Andrea Lo Vecchio, andrea.lovecchio@unina.it
- Recruiting
Ospedale dei Bambini "G.Di Cristina"
Palermo
Claudia Colomba, MD, claudia.colomba@unipa.it
- Recruiting
Ospedale di Parma
Parma
Susanna Maria Roberta Esposito, susannamariaroberta.esposito@unipr.it
- Recruiting
IRCCS Policlinico San Matteo
Pavia
Gian Luigi Marseglia, gl.marseglia@smatteo.pv.it
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Diego Peroni, diego.peroni@unipi.it
- Recruiting
Azienda USL Toscana Centro
Prato
Per Luigi Vasarri, pvasarri@usl4.toscana.it
- Recruiting
IRCCS Ospedale Pediatrico Bambin Gesù
Roma
Laura Lancella, laura.lancella@opbg.net
- Recruiting
Policlinico Universitario Agostino Gemelli IRCCS
Roma
Danilo Buonsenso, MD, danilo.buonsenso@policlinicogemelli.it
- Recruiting
Ospedale Regina Margherita
Torino
Silvia Garazzino, silvia.garazzino@unito.it
About this study
Official title: Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
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.
Read the 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.
- Conditions
- Tuberculosis Infection
- Medical subject headings
- Latent Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology of Tuberculosis
Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.
Measured: Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start22 Dec 2022
- Primary completion2 Jan 2033 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa Galli, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289660
- Sponsor's protocol ID
- PED-TB22
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age
- ClinicalTrials.gov ID
- NCT06289660
- Acronym / sponsor ID
- PED-TB22
- Conditions
- Tuberculosis Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 2 Jan 2033 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of Tuberculosis
Time frame: Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months
Describe the epidemiology of pediatric tuberculosis in the country also for the definition of control and prevention measures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Infection, run by Meyer Children's Hospital IRCCS at 17 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luisa Galli, MD (+390555662439, luisa.galli@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of Tuberculosis (time frame: Baseline-pretreatment, through treatment period completion, an average of 6 months, outcome at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.