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Not yet recruiting NCT07470541

Viromes in Infants Presenting With a Septic Syndrome

No phase Interventional Fever Viral Infection Bacterial Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biological samples.
Who it may be relevant to
Registry conditions: Fever, Viral Infection, Bacterial Infections. Basic parameters: 0 months — 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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)

Primary outcome measures

  • Rate of detection of pathogenic viruses in nasal cavity samples [Time frame: Day 0]
Secondary outcome measures (5)
  • Comparison of viral detection rates between febrile infants and controls [Time frame: Day 0]
  • Comparison of viruses associated with fever in infants under 3 months of age according to the final diagnosis (viral-origin fever vs bacterial-origin fever) in nasal swabs and stool samples and/or perianal swabs [Time frame: Day 0]
  • Analysis of biological markers of inflammation [Time frame: Day 0]
  • Correlation between the presence and number of pathogenic viruses and environmental and socioeconomic factors. [Time frame: Day 0]
  • Establishment of a biological sample collection (biobank) [Time frame: At the inclusion]

Eligibility criteria

Inclusion criteria

For participants :

  • Age < 3 months
  • Fever ≥38°C confirmed in pediatric emergency department

For control group :

  • Age < 3 months
  • Children requiring general anesthesia or managed in the pediatric emergency department, or during hospitalization or consultation, for a non-infectious condition requiring venipuncture

Exclusion criteria

For participants :

  • Lack of parental/legal guardian consent
  • Lack of affiliation with a social security scheme
  • Antibiotic treatment within 8 days prior to inclusion

For control group :

  • Lack of parental/legal guardian consent
  • Lack of affiliation with a social security scheme
  • Antibiotic treatment within 8 days prior to inclusion
  • Infectious episode within 8 days prior to inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Montpellier Hospital University — Montpellier

Identifiers

NCT: NCT07470541 · RECHMPL25_0133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗