FeverV-NOURSSENCT07470541
Viromes in Infants Presenting With a Septic Syndrome
A study testing biological samples in people with Fever and Viral Infection, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Fever, Viral Infection, Bacterial Infections
- What is being tested?
- biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Lack of affiliation with a social security scheme
- Antibiotic treatment within 8 days prior to inclusion
- Infectious episode within 8 days prior to inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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.
- Conditions
- Fever, Viral Infection, Bacterial Infections
- Being tested
- biological samples
- Keywords
- fever in infants under 3 months, Viruses, Respiratory infection multiplex PCR, Virome
- Medical subject headings
- Fever, Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Febrile infants | Other | Infants under 3 months presenting with fever ≥38°C in the pediatric emergency department. Receives: Biological: biological samples |
| Afebrile controls | Other | Infants under 3 months without infectious symptoms undergoing non-infectious procedures requiring venous sampling or anesthesia Receives: Biological: biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (5)
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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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."
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470541
- Sponsor's protocol ID
- RECHMPL25_0133
- Acronym
- V-NOURSSE
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viromes in Infants Presenting With a Septic Syndrome
- ClinicalTrials.gov ID
- NCT07470541
- Acronym / sponsor ID
- V-NOURSSE / RECHMPL25_0133
- Conditions
- Fever, Viral Infection, Bacterial Infections
- Keywords
- fever in infants under 3 months, Viruses, Respiratory infection multiplex PCR, Virome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Febrile infants | Other | Biological: biological samplesInfants under 3 months presenting with fever ≥38°C in the pediatric emergency department. |
| Afebrile controls | Other | Biological: biological samplesInfants under 3 months without infectious symptoms undergoing non-infectious procedures requiring venous sampling or anesthesia |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Lack of affiliation with a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplesNasal 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) | Biological | Afebrile controls, Febrile infants |
Primary outcome
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.
5 secondary outcomes
Comparison of viral detection rates between febrile infants and controls
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
Time frame: Day 0
Analysis of biological markers of inflammation
Time frame: Day 0
Correlation between the presence and number of pathogenic viruses and environmental and socioeconomic factors.
Time frame: Day 0
Establishment of a biological sample collection (biobank)
Time frame: At the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples in people with Fever and Viral Infection, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric JEZIORSKI, PU PH (+33467335798, e-jeziorski@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detection of pathogenic viruses in nasal cavity samples (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.