KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Acute Viral Bronchiolitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation |
- KL-6 rate [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
infants aged under 1 year
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Principal Investigator: | André LABBE, PU PH | CHU Estaing |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01437956 History of Changes |
| Other Study ID Numbers: | CHU-0104 |
| Study First Received: | September 12, 2011 |
| Last Updated: | September 20, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Calcineurin Bronchiolitis Epithelial lung injury |
Rhinovirus Respiratory Syncytial Virus Asthma |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis, Viral Lung Injury Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Virus Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013