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Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06322277
Enrollment
1
Registered
2024-03-21
Start date
2021-05-04
Completion date
2025-03-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

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.

Interventions

OTHERAnalysis of biological sample

Confermation of type of infection with RT-PCR.

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae.After 3 years from the beginning of the studyMolecular surveillance data analysis of pertussis, respiratory virus disease, invasive bacterial diseases. We will measure the incidence rate of predictable disease with vaccination, stratifying by biological sex, age, other risk factors, and severity of infection during the project. (IBD) due to capsule bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae) and other vaccine-preventable infections (e.g., viral flu)

Secondary

MeasureTime frameDescription
Frequency of principal serotype, serogroups of pathogens causative for VPDs.After 3 years from the beginning of the studyAnalysis of molecular characteristics of germs identified in pediatric subjects with VPDs.
Number of meeting to diffuse the NETVAC results in Tuscany network.After 3 years and 6 months from the beginning of the studyExpand and spread knowledge of the importance of active and molecular surveillance in the pediatric network consisting of hospital centers and family pediatricians in Tuscany through the organization of at least two meetings/year for three years between centers hospitals in Tuscany, family pediatricians within the regional pediatric network and pediatric scientific societies in order to disseminate the role of molecular diagnosis in the active surveillance against vaccine-preventable infectious diseases.

Countries

Italy

Contacts

Primary ContactMassimo Resti
massimo.resti@meyer.it0555662566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026