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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01437956

Enrollment

200

Registered

2011-09-21

Start date

2011-10-31

Completion date

2016-10-31

Last updated

2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Viral Bronchiolitis

Keywords

Calcineurin, Bronchiolitis, Epithelial lung injury, Rhinovirus, Respiratory Syncytial Virus, Asthma

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
KL-6 rate	At day 1

Contacts

Primary ContactPatrick LACARIN

placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results