Clinical trial NCT06322277: Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.
Official title: The Regional Pediatric Network and the Use of Low-cost Molecular Diagnostic Techniques Cost as a New Management and Surveillance Model for Diseases Preventable by Vaccinations.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Infections
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Vaccine-preventable disease (VPD) surveillance should be a priority throughout the world. In Italy, however, there is limited attention to the epidemiology of VPDs, with the consequence that their incidence is largely underestimated. Although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing VPDs are not identified the etiological agents causing the major and most severe infectious diseases in childhood. Several reasons underlie the underestimation. For example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. For example the limited use of low-cost high-sensitivity techniques such as real-time PCR, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. Therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving VPD surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 0-18 years with infectious disease (bacterial or viral) diagnosed by molecular techniques at the AOU Meyer Immunology Laboratory
* Obtaining informed consent

Exclusion Criteria:

* Individuals with concomitant diseases such as cystic fibrosis, known immunodeficiency, or with infection suspected nosocomial (hospitalization or hospital admission within 15 days prior to the onset of symptoms) will be excluded from the study

Primary outcomes:
measure: Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae.
timeFrame: After 3 years from the beginning of the study
Secondary outcomes:
measure: Frequency of principal serotype, serogroups of pathogens causative for VPDs.
timeFrame: After 3 years from the beginning of the study
measure: Number of meeting to diffuse the NETVAC results in Tuscany network.
timeFrame: After 3 years and 6 months from the beginning of the study
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Florence
country: Italy
facility: Immunology Laboratory Meyer Children's Hospital, IRCCS
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Pisa
country: Italy
facility: UO Pediatria Universitaria Ospedale S.Chiara
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Massimo Resti
role: PRINCIPAL_INVESTIGATOR
References: