Acute Viral BronchiolitisNCT01437956
KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis
An observational study of Acute Viral Bronchiolitis, run by University Hospital, Clermont-Ferrand.
Trial summary
Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Read more about this study
- Who is it for?
- Ages 1 day to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Acute Viral Bronchiolitis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2016
- Phase
- Observational
- 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 1 day to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants aged under 1 year
Who may be able to join
- Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory.
- Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment)
Who cannot join
- Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion
- Controls: infectious documented disease, respiratory symptoms
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation
Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.
Read the detailed description
Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.
- Conditions
- Acute Viral Bronchiolitis
- Keywords
- Calcineurin, Bronchiolitis, Epithelial lung injury, Rhinovirus, Respiratory Syncytial Virus, Asthma
- Medical subject headings
- Bronchiolitis, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
KL-6 rate
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André LABBE, PU PH, Principal investigator, CHU Estaing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437956
- Sponsor's protocol ID
- CHU-0104
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation
- ClinicalTrials.gov ID
- NCT01437956
- Acronym / sponsor ID
- CHU-0104
- Conditions
- Acute Viral Bronchiolitis
- Keywords
- Calcineurin, Bronchiolitis, Epithelial lung injury, Rhinovirus, Respiratory Syncytial Virus, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Sep 2011 (estimated)
- 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.
Serum KL-6 protein has been described as a biomarker of epithelial lung injury in Respiratory Syncytial Virus bronchiolitis. The investigators can imagine that epithelial injury intensity has consequences on immediate and later respiratory prognosis. Furthermore, this prognosis seems to be different according to the respiratory causative virus. The investigators propose to study, during an epidemic season, the correlation between KL-6 levels and clinical severity, and the type of viral infection.
Detailed description
Prospective, monocentric, case-control and transversal study Primary end-point: correlation between serum KL-6 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in Paediatric Emergency Unit Secondary end-points: respiratory virus detected by EIA and RT-PCR, phylogenetic study of rhinovirus, length of hospitalisation, immediate morbidity and mortality, risk of asthma at the age of three years old.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants aged under 1 year
Key inclusion criteria (2 listed)
- Cases: Inaugural acute bronchiolitis in infant aged under 1 year; bronchiolitis is defined by rhinorrhea and/or cough, dyspnea, associated with clinical or radiological distension, wheezing or crackling or brake expiratory.
- Controls: Infant aged under 1 year with blood sample test performed for a non-infectious disease (preoperative assessment)
Key exclusion criteria (2 listed)
- Cases: bronchopulmonary dysplasia, prematurity, cystic fibrosis, immunodeficiency, primary ciliary dyskinesia, congenital cardiopathy, use of corticotherapy the week between inclusion
- Controls: infectious documented disease, respiratory symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KL-6 rate
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
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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.
André LABBE, PU PH principal investigator
CHU Estaing
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Viral Bronchiolitis, run by University Hospital, Clermont-Ferrand.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KL-6 rate (time frame: At day 1). 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 21 Sep 2011.