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Acute Bronchiolitis and Severity Markers: Interest in Protein CC16 (CC16)

Primary Purpose

Acute Bronchiolitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protein CC16
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchiolitis focused on measuring Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers

Eligibility Criteria

1 Day - 1 Year (Child)All SexesAccepts 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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

acute bronchiolitis

Arm 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

Outcomes

Primary Outcome Measures

Serum CC16 rate

Secondary Outcome Measures

Urinary CC16 rate
SP-D rates
sRAGE rates

Full Information

First Posted
November 28, 2016
Last Updated
December 2, 2016
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02984046
Brief Title
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
Acronym
CC16
Official Title
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchiolitis
Keywords
Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acute bronchiolitis
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Protein CC16
Primary Outcome Measure Information:
Title
Serum CC16 rate
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Urinary CC16 rate
Time Frame
at day 1
Title
SP-D rates
Time Frame
at day 1
Title
sRAGE rates
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André LABBE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
André LABBE

12. IPD Sharing Statement

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Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

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