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Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02984046
Acronym
CC16
Enrollment
200
Registered
2016-12-06
Start date
2015-11-30
Completion date
2019-01-31
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis

Keywords

Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers

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.

Interventions

DRUGProtein CC16

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Serum CC16 rateat day 1

Secondary

MeasureTime frame
Urinary CC16 rateat day 1
SP-D ratesat day 1
sRAGE ratesat day 1

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr0473751195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026