Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Acute Bronchiolitis Clinical Trial

— CC16  

Official title:

Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984046
• Other study ID #: CHU-0294
• Secondary ID: 2015-A01587-42
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: December 2, 2016
• Start date: November 2015
• Est. completion date: January 2019

Study information

• Verified date: December 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Drug:
• Protein CC16

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum CC16 rate		at day 1	Yes
Secondary	Urinary CC16 rate		at day 1	Yes
Secondary	SP-D rates		at day 1	Yes
Secondary	sRAGE rates		at day 1	Yes