Viromes in Infants Presenting With a Septic Syndrome

NCT07470541 | Not Yet Recruiting

• 1 other identifier: RECHMPL25_0133
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fever; Viral Infection; Bacterial Infections

Keywords

fever in infants under 3 months; Viruses; Respiratory infection multiplex PCR; Virome

Outcome Measures

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.

  Day 0

Secondary Outcomes (5)

• Comparison of viral detection rates between febrile infants and controls

  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

  Day 0

• Analysis of biological markers of inflammation

  Day 0

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

  Day 0

• Establishment of a biological sample collection (biobank)

  At the inclusion

Study Arms (2)

Febrile infants

OTHER

Infants under 3 months presenting with fever ≥38°C in the pediatric emergency department.

Biological: biological samples

Afebrile controls

OTHER

Infants under 3 months without infectious symptoms undergoing non-infectious procedures requiring venous sampling or anesthesia

Biological: biological samples

Interventions

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)

Afebrile controls; Febrile infants

Eligibility Criteria

• Age: 0 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• For participants :
• Lack of parental/legal guardian consent
• Lack of affiliation with a social security scheme
• For control group :
• Lack of parental/legal guardian consent
• Lack of affiliation with a social security scheme

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier Hospital University

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Fever; Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Bacterial Infections and Mycoses

Central Study Contacts

Eric JEZIORSKI, PU PH

CONTACT

+33467335798; e-jeziorski@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Viral infections are epidemic and strongly seasonal. Therefore, we plan to include children during both the autumn-winter and spring-summer periods. Two groups will be constituted: Period A (spring-summer): May 2 to August 31 - 50 febrile infants included. Period B (autumn-winter): October 1 to February 28 - 50 febrile infants included.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center RIPH-2 study. Two groups of subjects will be recruited: One group of febrile infants (n = 100) One group of control infants (n = 30) Patients will be recruited from the pediatric emergency department in Montpellier. Control subjects will be enrolled through an existing pathway at the Montpellier University Hospital (CHU de Montpellier), as part of preoperative assessments.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

FR (1)