Viromes in Infants Presenting With a Septic Syndrome (V-NOURSSE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Infections; Fever; Viral Infection
• Intervention / Treatment: Biological: biological samples

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric JEZIORSKI, PU PH; Phone Number: +33467335798; Email: e-jeziorski@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier Hospital University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Febrile infants; Infants under 3 months presenting with fever ≥38°C in the pediatric emergency department.	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)
Other: Afebrile controls; Infants under 3 months without infectious symptoms undergoing non-infectious procedures requiring venous sampling or anesthesia	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	Day 0
Analysis of biological markers of inflammation	Inflammatory markers analyzed include: CRP, PCT, MxA, plasma CD14, and cellular markers (CD169, CD14, CD64, HLA-DR)	Day 0
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	Day 0
Establishment of a biological sample collection (biobank)	Study of the bacterial virome integrated into a separately funded project entitled "Metagenomics for a Closer Look at Early-Life Exposures to Viruses."	At the inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Virome; Viruses; fever in infants under 3 months; Respiratory infection multiplex PCR
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Virus Diseases; Fever; Bacterial Infections
• Other Study ID Numbers: RECHMPL25_0133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No