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

Bacterial Infections Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322277
• Other study ID #: NETVAC
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Massimo Resti
• Phone: 0555662566
• Email: massimo.resti[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: March 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Other:
• Analysis of biological sample
Confermation of type of infection with RT-PCR.

Locations

Country	Name	City	State
Italy	Ospedale San Donato	Arezzo
Italy	Immunology Laboratory Meyer Children's Hospital, IRCCS	Florence
Italy	Meyer Children's Hospital IRCCS	Florence
Italy	UO Pediatria Universitaria Ospedale S.Chiara	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of major VPDs (vaccine-preventable infectious diseases): pertussis, influenza virus, respiratory syncytial virus, S.pneumoniae, N.meningitidis, H.influenzae.	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)	After 3 years from the beginning of the study
Secondary	Frequency of principal serotype, serogroups of pathogens causative for VPDs.	Analysis of molecular characteristics of germs identified in pediatric subjects with VPDs.	After 3 years from the beginning of the study
Secondary	Number of meeting to diffuse the NETVAC results in Tuscany network.	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.	After 3 years and 6 months from the beginning of the study