Acute Bronchiolitis and Severity Markers: Interest in Pro... | NCT02984046

Studies
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

NCT02984046

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Dec 6, 2016Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Acute Bronchiolitis

Interventions

Protein CC16

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-A01587-42	Other Identifier	2015-A01587-42

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Aug 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 6, 2016Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
acute bronchiolitis	Experimental	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	Drug: Protein CC16

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein CC16	Drug		acute bronchiolitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum CC16 rate		at day 1

Secondary Outcomes

Measure	Description	Time Frame
Urinary CC16 rate		at day 1
SP-D rates		at day 1
sRAGE rates

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	0473751195		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
André LABBE	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France