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Acute Bronchiolitis and Severity Markers: Interest in Protein CC16 (CC16)

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ClinicalTrials.gov Identifier: NCT02984046
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Acute Bronchiolitis Drug: Protein CC16 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
Study Start Date : November 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Serum CC16 rate [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984046


Contacts
Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: André LABBE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: André LABBE University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02984046     History of Changes
Other Study ID Numbers: CHU-0294
2015-A01587-42 ( Other Identifier: 2015-A01587-42 )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Acute bronchiolitis
RSV
CC16
SP-D
sRAGE
Severity
Biomarkers

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections