NCT02984046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

2.8 years

First QC Date

November 28, 2016

Last Update Submit

December 2, 2016

Conditions

Acute Bronchiolitis

Keywords

Acute bronchiolitisRSVCC16SP-DsRAGESeverityBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Serum CC16 rate

    at day 1

Secondary Outcomes (3)

  • Urinary CC16 rate

    at day 1

  • SP-D rates

    at day 1

  • sRAGE rates

    at day 1

Study Arms (1)

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

Protein CC16DRUG
acute bronchiolitis

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants under 1 year old hospitalized for acute bronchiolitis

You may not qualify if:

  • Broncho dysplasia
  • Preterm under 34 weeks
  • Cystic fibrosis
  • Immune deficiency
  • Suspicion of primary ciliary dyskinesia
  • Congenital heart disease
  • Acute renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

  • André LABBE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 6, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2018

Study Completion

January 1, 2019

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

FR(1)