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

Not Applicable

Recruiting

• Conditions: Bacterial Infections
• Interventions: Other: Analysis of biological sample

• Registration Number: NCT06322277
• Lead Sponsor: Meyer Children's Hospital IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with viral/bacterial infection	Analysis of biological sample	-

Primary Outcome Measures

Name	Time	Method
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 study	Molecular 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 Outcome Measures

Name	Time	Method
Frequency of principal serotype, serogroups of pathogens causative for VPDs.	After 3 years from the beginning of the study	Analysis 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 study	Expand 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.

Trial Locations

Locations (4)

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy

Ospedale San Donato; 🇮🇹 Arezzo, Italy

Immunology Laboratory Meyer Children's Hospital, IRCCS; 🇮🇹 Florence, Italy

UO Pediatria Universitaria Ospedale S.Chiara; 🇮🇹 Pisa, Italy