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Viromes in Infants Presenting With a Septic Syndrome

NCT07470541 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-17

No results posted yet for this study

Summary

Fever in infants younger than 3 months is a common reason for emergency department visits and is associated with a significant risk of serious bacterial infections. Because it is difficult to distinguish bacterial from viral infections at presentation, management is often aggressive and includes invasive procedures, hospitalization, and empiric antibiotic therapy.

Despite advances in molecular diagnostics, the etiology of fever remains unidentified in a substantial proportion of cases. This study aims to assess the presence of pathogenic viruses in respiratory and intestinal samples from febrile infants younger than 3 months compared with afebrile controls, and to explore associations with clinical, biological, environmental, and socio-economic factors

Conditions

Interventions

BIOLOGICAL

biological samples

Nasal cavity swab (multiplex RT-PCR respiratory viral panel) Stool sample or peri-anal swab Blood sampling (700 µL EDTA + capillary drop for MxA testing) Biomarker analysis (CRP, PCT, MxA, CD169, CD14, CD64, HLA-DR)

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470541 on ClinicalTrials.gov