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
  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

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

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

infants aged under 1 year

Criteria

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 ClinicalTrials.gov identifier: NCT01437956

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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
Thoracic Injuries
Wounds and Injuries
Virus Diseases

ClinicalTrials.gov processed this record on September 22, 2014