Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Acute Bronchiolitis

Treatments: Drug: Protein CC16

Study type: Interventional

Funder types: Other

Identifiers

NCT02984046

CHU-0294

2015-A01587-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 day to 1 year old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

acute bronchiolitis

Experimental group

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

Treatment:

Drug: Protein CC16