NCT01437956

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

4.6 years

First QC Date

September 12, 2011

Last Update Submit

September 20, 2011

Conditions

Acute Viral Bronchiolitis

Keywords

CalcineurinBronchiolitisEpithelial lung injuryRhinovirusRespiratory Syncytial VirusAsthma

Outcome Measures

Primary Outcomes (1)

  • KL-6 rate

    At day 1

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

infants aged under 1 year

You may qualify if:

  • 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)

You may not qualify if:

  • Controls: infectious documented disease, respiratory symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BronchiolitisAsthma

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • André LABBE, PU PH

    CHU Estaing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 21, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

September 21, 2011

Record last verified: 2011-09