CClinicalTrials.gg
Status unknownNCT02984046CC16Updated Dec 6, 2016

Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

An interventional study of Protein CC16 in Acute Bronchiolitis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 1 Day to 1 Year, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-06.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
1 Day to 1 Year
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Bronchiolitis

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Keywords

  • Acute bronchiolitis
  • RSV
  • CC16
  • SP-D
  • sRAGE
  • Severity
  • Biomarkers
03

In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 249 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Year
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Infants under 1 year old hospitalized for acute bronchiolitis

Exclusion criteria

Exclusion Criteria:

  • Broncho dysplasia
  • Preterm under 34 weeks
  • Cystic fibrosis
  • Immune deficiency
  • Suspicion of primary ciliary dyskinesia
  • Congenital heart disease
  • Acute renal failure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Protein CC16

Interventions

  • DrugProtein CC16
06

What researchers measure

Primary outcomes

  1. Serum CC16 rate

    Time frame: at day 1

Secondary outcomes

  1. Urinary CC16 rate

    Time frame: at day 1

  2. SP-D rates

    Time frame: at day 1

  3. sRAGE rates

    Time frame: at day 1

07

Study locations

1 of 1 sites recruiting
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02984046
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Dec 6, 2016
Start date
Nov 2015
Primary completion
Aug 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Dec 6, 2016

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
0473751195
André LABBE
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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