NCT07470541

Viromes in Infants Presenting With a Septic Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 0 Months – 3 Months
• Healthy volunteers: Accepted

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

Detailed description

Fever in infants under three months of age is a high-stakes clinical condition because severe bacterial infections occur in up to 20-25% of cases, while clinical signs alone cannot reliably distinguish bacterial from viral illness. Due to immune immaturity, management is often aggressive, involving hospitalization, lumbar puncture, and intravenous antibiotics. Although molecular diagnostics (multiplex PCR), bacterial biomarkers (CRP, procalcitonin), and clinical algorithms have improved care, approximately one quarter of cases still lack a confirmed etiology-most often because viral infections are difficult to definitively establish. This research project aims to improve etiological diagnosis in febrile young infants by systematically evaluating multiplex molecular tests and novel host-response biomarkers (including interferon-induced proteins) using minimally invasive nasal swabs. By correlating these results with final clinical diagnoses-classified as confirmed or probable viral or bacterial infections-the study seeks to clarify the role of these diagnostic tools in early infancy. Seasonal variations as well as environmental and socio-economic factors will be analyzed. A biological sample collection will be constituted for future analyses.The ultimate goal is to enhance diagnostic precision, reduce unnecessary hospitalizations and antibiotic exposure, and optimize the management of febrile infants.

Conditions

• Fever
• Viral Infection
• Bacterial Infections

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2026-03-13
• Last updated: 2026-03-17

Locations

1 site across 1 country: France