Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01437956
Status:
UNKNOWN
Last Update Posted:
2011-09-21
First Post:
2011-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Acute Bronchiolitis in Infants: Analysis of a Biomarker of Epithelial Lung Injury - Clinical and Virological Correlation
Status:
UNKNOWN
Status Verified Date:
2011-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: