An interventional study of biological samples in Fever, Viral Infection and Bacterial Infections, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 0 Months to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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
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.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 130 is close to the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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For control group :
Exclusion criteria :
For participants :
For control group :
Infants under 3 months presenting with fever ≥38°C in the pediatric emergency department.
Biological: biological samples
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)
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
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
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
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
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
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."
Time frame: At the inclusion
Start is estimated for Apr 2026; primary completion for Mar 2028, 23 months later.
Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 23 months is above that.
Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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