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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand Identifier:
First received: September 12, 2011
Last updated: September 20, 2011
Last verified: September 2011
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.

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

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • KL-6 rate [ Time Frame: At day 1 ]

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)
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.

Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01437956

Contact: Patrick LACARIN 04 73 75 11 95

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: André LABBE, PU PH CHU Estaing
  More Information

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01437956     History of Changes
Other Study ID Numbers: CHU-0104
Study First Received: September 12, 2011
Last Updated: September 20, 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Epithelial lung injury
Respiratory Syncytial Virus

Additional relevant MeSH terms:
Lung Injury
Bronchiolitis, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Thoracic Injuries
Wounds and Injuries
Virus Diseases processed this record on September 21, 2017