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

NCT06322277 | Recruiting

• 1 other identifier: NETVAC
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of principal serotype, serogroups of pathogens causative for VPDs.

  After 3 years from the beginning of the study

• Number of meeting to diffuse the NETVAC results in Tuscany network.

  After 3 years and 6 months from the beginning of the study

Study Arms (1)

Patients with viral/bacterial infection

OTHER

Other: Analysis of biological sample

Interventions

Analysis of biological sample OTHER

Confermation of type of infection with RT-PCR.

Patients with viral/bacterial infection

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (4)

Ospedale San Donato

Arezzo, Italy

RECRUITING

Immunology Laboratory Meyer Children's Hospital, IRCCS

Florence, Italy

RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

UO Pediatria Universitaria Ospedale S.Chiara

Pisa, Italy

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Massimo Resti

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Resti

CONTACT

0555662566; massimo.resti@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 21, 2024
• Study Start: May 4, 2021
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

IT (4)