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Viromes in Infants Presenting With a Septic Syndrome

ConditionsFeverViral InfectionBacterial Infections
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age < 3 months

Fever ≥38°C confirmed in pediatric emergency department

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

Disqualifiers

Lack of parental/legal guardian consent

Lack of affiliation with a social security scheme

Antibiotic treatment within 8 days prior to inclusion

Lack of parental/legal guardian consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • biological samples

    Biological/Vaccine

    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)

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Febrile infantsOther 1 intervention
Group B: Afebrile controlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Rate of detection of pathogenic viruses in nasal cavity samples

Proportion of infants with at least one pathogenic virus detected by multiplex RT-PCR in nasal cavity samples.

Time frame
Day 0

Secondary outcomes

1

Comparison of viral detection rates between febrile infants and controls

Viruses known to be pathogenic include: RSV, Influenza A, Influenza B, COVID-19, Parainfluenza virus (types 1, 2, 3, and 4), Rhinovirus, Coronavirus 229, Coronavirus NL63, Coronavirus OC43, Enterovirus, Adenovirus, Bocavirus, Metapneumovirus

Time frame
Day 0
2

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

Final clinical diagnosis categories: * Confirmed bacterial infection: Identification of a bacterial pathogen in a normally sterile site (by culture, antigen testing, or PCR). * Probable bacterial infection: No pathogen identified in a sterile site, but clinical evidence supporting bacterial infection (signs of sepsis or localized infection) and/or elevated bacterial biomarkers (CRP \> 20 mg/L, PCT \> 0.5 ng/L), with favorable response to antibiotic therapy. * Probable viral infection: No virus identified and no evidence supporting bacterial infection. * Confirmed viral infection: Identification of at least one pathogenic virus, with compatible clinical manifestations and no evidence supporting bacterial infection.

Time frame
Day 0
3

Analysis of biological markers of inflammation

Inflammatory markers analyzed include: CRP, PCT, MxA, plasma CD14, and cellular markers (CD169, CD14, CD64, HLA-DR)

Time frame
Day 0
4

Correlation between the presence and number of pathogenic viruses and environmental and socioeconomic factors.

Environmental factors: Living environment, number of rooms in the household, and number of people living in the home. Socioeconomic factors: Daycare attendance, number of siblings, and parents' occupations

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: