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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2011 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01437956
First received: September 12, 2011
Last updated: September 20, 2011
Last verified: September 2011

September 12, 2011
September 20, 2011
October 2011
May 2016   (final data collection date for primary outcome measure)
KL-6 rate [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01437956 on ClinicalTrials.gov Archive Site
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KL-6 Protein as a Biomarker of Lung Injury in Viral Bronchiolitis
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

infants aged under 1 year

Acute Viral Bronchiolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
October 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
Yes
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
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NCT01437956
CHU-0104
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University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
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Principal Investigator: André LABBE, PU PH CHU Estaing
University Hospital, Clermont-Ferrand
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP