Neonatal Echovirus 11 infections in Italy: virological, genomic and clinical insights
Official title: Neonatal Enterovirus Infections in Italy: Virological Characterization, Genomic and Clinical-epidemiological Insights on Echovirus 11
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07356583 · Data updated 2026-11-12
This project will test whether sequencing virus samples from newborns with enterovirus infections, especially Echovirus 11, helps explain how the virus causes illness in the first weeks of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 28 Days |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | August 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07356583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates admitted to the NICU with suspected or confirmed enterovirus infection who have sufficient residual clinical samples (at least 1 mL nasal swab) available for sequencing.
✕Probably not a fit
Infants without sufficient sample volume, older children, or neonates without enterovirus infection are unlikely to benefit directly from this observational effort.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects respiratory and residual clinical samples from consecutive neonates admitted to the NICU at Fondazione IRCCS Policlinico San Matteo in Pavia. Samples with sufficient volume (≥1 mL nasal swab) will undergo virological characterization, including next-generation sequencing to obtain viral genomes. Genomic data will be linked with clinical and epidemiological information to identify viral variants, transmission patterns, and associations with severe outcomes such as sepsis, respiratory complications, or gastrointestinal disease. No investigational treatments are given; the work is laboratory and data-driven to improve understanding of neonatal enterovirus infections.
Why it matters
Potential benefit: If successful, this work could improve diagnosis, outbreak detection, and infection-control strategies for newborns with enterovirus infections and help guide clinical care.
How similar studies have gone: Genomic surveillance and sequencing of enteroviruses have been successfully used in prior outbreaks, though detailed neonatal-focused genomic data for Echovirus 11 remain relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Samples from consecutive neonates admitted to neonatal intensive care unit. Exclusion Criteria: Insufficient residual samples (volume less than 1 mL of nasal swab) will be excluded from the study
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Antonio Piralla
- Email: a.piralla@smatteo.pv.it
- Phone: +390382502420
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.