Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Not Applicable

• Conditions: Acute Bronchiolitis
• Interventions: Drug: Protein CC16

• Registration Number: NCT02984046
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-11-28
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-06
• Last Update Posted: 2016-12-06
• Primary Completion: 2018-08
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acute bronchiolitis	Protein CC16	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

Primary Outcome Measures

Name	Time	Method
Serum CC16 rate	at day 1

Secondary Outcome Measures

Name	Time	Method
Urinary CC16 rate	at day 1
SP-D rates	at day 1
sRAGE rates	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France