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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


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
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