Using low-cost tests to improve surveillance of vaccine-preventable diseases.
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.
This study is testing if low-cost tests can help find vaccine-preventable diseases in children in Italy to improve vaccination strategies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 4 sites (Arezzo and 3 other locations) |
| Trial ID | NCT06322277 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the surveillance of vaccine-preventable diseases (VPDs) in Italy by utilizing low-cost molecular diagnostic techniques, such as real-time PCR, to improve the identification of pathogens. The research will involve analyzing biological samples from children aged 0-18 years diagnosed with infectious diseases at the AOU Meyer Immunology Laboratory. By increasing the sensitivity of pathogen detection, the study seeks to provide better epidemiological data and inform vaccination strategies. The multicenter approach will allow for a broader assessment of VPD incidence across different regions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-18 years with infectious diseases diagnosed by molecular techniques.
Not a fit: Patients with concomitant diseases such as cystic fibrosis or known immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and prevention of vaccine-preventable diseases in children.
How similar studies have performed: Other studies have shown success in using molecular diagnostic techniques for pathogen identification, suggesting a promising approach for this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arezzo and 3 other locations
- 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)
Study contacts
- Principal investigator: Massimo Resti — Meyer Children's Hospital IRCCS
- Study coordinator: Massimo Resti
- Email: massimo.resti@meyer.it
- Phone: 0555662566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.