KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

Official title:

Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01437956
• Other study ID #: CHU-0104
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2011
• Last updated: September 20, 2011
• Start date: October 2011
• Est. completion date: October 2016

Study information

• Verified date: September 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral
• Lung Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KL-6 rate		At day 1	Yes