InfluenzaBMIGNCT03231995
Biomarkers for the Prognosis of Influenza in Children
A study testing Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5. in people with Influenza, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Influenza
- What is being tested?
- Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2019to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 5 years
- Seen in an emergency department with influenza confirmed by a positive test (polumerase chain reaction, rapide antigen detection test).
Who cannot join
- Presence of associated significant comorbidity (chronic respiratory, cardiac, neurological or metabolic pathology, prematurity, known immunodeficiency)
- Documented non-respiratory bacterial infection
- No consent
- Patient not affiliated to a national health cover
Trial locations and contacts
2 sites in 1 country.
France2 sites
CIC groupement Hospitalier Est - Hospices Civils de Lyon
Lyon, 69317
Hopital Nord
Saint-Etienne
About this study
Official title: Prospective Multicentre Study to Determine Respiratory Microbiome Biomarkers for the Prognostic of Clinical Course of Influenza in Children
Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms.
Hypotheses :
- The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication)
- The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.
- Conditions
- Influenza
- Being tested
- Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.
- Keywords
- Severe influenza, biomarkers, respiratory microbiome, prognosis
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.Biological
Analyses will be performed on nasopharyngeal specimen collected at D0, D1, D2 and D5.
Definition and validation of nasopharyngeal microbiome biomarkers (bacterial, viral, transcriptomic signature)
| Study group | Role | What they receive |
|---|---|---|
| Respiratory microbiome biomarkers | Experimental | Not described Receives: Biological: Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition and evaluation of a microbial signature discriminating patients developing severe influenza from those developing moderate influenza
On nasopharyngeal specimen collected at inclusion, a microbial signature will be defined as a limited number of bacterial genomic groups (OTU Operational Taxonomic Unit), that will help discriminate the 2 groups of patients (evolution toward a severe or a moderate influenza, evaluated at hospital discharge).
Measured: Day 30
Secondary outcomes (3)
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
We will analyze the different dynamics of the composition of the microbiome associated with different influenza evolutions. The qualitative and quantitative evolution of the microbial species present in the respiratory specimens will be evaluated by sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens performed on Day 1.
Measured: Day 1
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
We will analyze the different dynamics of the composition of the microbiome associated with different influenza evolutions. The qualitative and quantitative evolution of the microbial species present in the respiratory specimens will be evaluated by sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens performed on day 2
Measured: Day 2
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
We will analyze the different dynamics of the composition of the microbiome associated with different influenza evolutions. The qualitative and quantitative evolution of the microbial species present in the respiratory specimens will be evaluated by sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens performed on day 5
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start15 Jan 2019
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231995
- Sponsor's protocol ID
- 69HCL17_0175
- Other IDs
- 2017-A03035-48
- Acronym
- BMIG
- Status last verified
- Jun 2022
- First submitted
- 25 Jul 2017
- Last updated
- 8 Jun 2022
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Study to Determine Respiratory Microbiome Biomarkers for the Prognostic of Clinical Course of Influenza in Children
- ClinicalTrials.gov ID
- NCT03231995
- Acronym / sponsor ID
- BMIG / 69HCL17_0175
- Conditions
- Influenza
- Keywords
- Severe influenza, biomarkers, respiratory microbiome, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 27 Jul 2017 (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.
Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms.
Hypotheses :
- The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication)
- The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory microbiome biomarkers | Experimental | Biological: Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age < 5 years
- Seen in an emergency department with influenza confirmed by a positive test (polumerase chain reaction, rapide antigen detection test).
Key exclusion criteria (4 listed)
- Presence of associated significant comorbidity (chronic respiratory, cardiac, neurological or metabolic pathology, prematurity, known immunodeficiency)
- Documented non-respiratory bacterial infection
- No consent
- Patient not affiliated to a national health cover
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 |
|---|---|---|
| Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.Analyses will be performed on nasopharyngeal specimen collected at D0, D1, D2 and D5. Definition and validation of nasopharyngeal microbiome biomarkers (bacterial, viral, transcriptomic signature) | Biological | Respiratory microbiome biomarkers |
Primary outcome
Definition and evaluation of a microbial signature discriminating patients developing severe influenza from those developing moderate influenza
Time frame: Day 30
On nasopharyngeal specimen collected at inclusion, a microbial signature will be defined as a limited number of bacterial genomic groups (OTU Operational Taxonomic Unit), that will help discriminate the 2 groups of patients (evolution toward a severe or a moderate influenza, evaluated at hospital discharge).
3 secondary outcomes
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
Time frame: Day 1
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
Time frame: Day 2
sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5. in people with Influenza, run by Hospices Civils de Lyon at 2 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition and evaluation of a microbial signature discriminating patients developing severe influenza from those developing moderate influenza (time frame: Day 30). 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 8 Jun 2022.