Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

NCT ID: NCT02984046

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-01-31

Brief Summary

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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

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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

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Acute Bronchiolitis

Keywords

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Acute bronchiolitis RSV CC16 SP-D sRAGE Severity Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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acute bronchiolitis

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

Group Type EXPERIMENTAL

Protein CC16

Intervention Type DRUG

Interventions

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Protein CC16

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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André LABBE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 0473751195

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

Other Identifiers

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2015-A01587-42

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0294

Identifier Type: -

Identifier Source: org_study_id