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NCT Number: NCT07470541

Viromes in Infants Presenting With a Septic Syndrome

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

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Key information

Conditions

Fever Bacterial Infections Bacterial Infections and Mycoses Body Temperature Changes Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Viral Infection Virus Diseases

Age range

0 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier Hospital University

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological samples

Biological

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 outcomes

  1. Rate of detection of pathogenic viruses in nasal cavity samples

    Time frame: Day 0

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

Secondary outcomes

  1. Comparison of viral detection rates between febrile infants and controls

    Time frame: Day 0

    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

  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

    Time frame: Day 0

    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.

  3. Analysis of biological markers of inflammation

    Time frame: Day 0

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

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

    Time frame: Day 0

    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

  5. Establishment of a biological sample collection (biobank)

    Time frame: At the inclusion

    Study of the bacterial virome integrated into a separately funded project entitled "Metagenomics for a Closer Look at Early-Life Exposures to Viruses."

Study contacts

Contact information is provided by the study sponsor or research team.

Eric JEZIORSKI, PU PH

CONTACT

[email protected]

+33467335798

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: V-NOURSSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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