NCT02984046

Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 1 Day – 1 Year
• Healthy volunteers: Accepted

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.

Conditions

• Acute Bronchiolitis

Interventions

Type	Name	Description
DRUG	Protein CC16

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-08-01
• Completion: 2019-01-01
• First posted: 2016-12-06
• Last updated: 2016-12-06

Locations

1 site across 1 country: France