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Clinical Trials/NCT02984046
NCT02984046
Unknown
Not Applicable

Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

University Hospital, Clermont-Ferrand1 site in 1 country200 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Protein CC16
Conditions
Acute Bronchiolitis
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
200
Locations
1
Primary Endpoint
Serum CC16 rate
Last Updated
9 years ago

Overview

Brief Summary

Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.

Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma.

Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.

Detailed Description

Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 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: correlation with urinary CC16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
January 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Infants under 1 year old hospitalized for acute bronchiolitis

Exclusion Criteria

  • Broncho dysplasia
  • Preterm under 34 weeks
  • Cystic fibrosis
  • Immune deficiency
  • Suspicion of primary ciliary dyskinesia
  • Congenital heart disease
  • Acute renal failure

Arms & Interventions

acute bronchiolitis

Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system

Intervention: Protein CC16

Outcomes

Primary Outcomes

Serum CC16 rate

Time Frame: at day 1

Secondary Outcomes

  • Urinary CC16 rate(at day 1)
  • SP-D rates(at day 1)
  • sRAGE rates(at day 1)

Study Sites (1)

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