Viromes in Infants Presenting With a Septic Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

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

Eligibility

Primary outcome measure(s)

• Rate of detection of pathogenic viruses in nasal cavity samples — Day 0
  Proportion of infants with at least one pathogenic virus detected by multiplex RT-PCR in nasal cavity samples.

Trial sites (1)

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