Acute BronchiolitisCC16NCT02984046
Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
A study testing Protein CC16 in people with Acute Bronchiolitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- Protein CC16
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants under 1 year old hospitalized for acute bronchiolitis
Who cannot join
- Broncho dysplasia
- Preterm under 34 weeks
- Cystic fibrosis
- Immune deficiency
- Suspicion of primary ciliary dyskinesia
- Congenital heart disease
- Acute renal failure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
André LABBE
About this study
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.
- Conditions
- Acute Bronchiolitis
- Being tested
- Protein CC16
- Keywords
- Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein CC16Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Protein CC16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CC16 rate
Measured: at day 1
Secondary outcomes (3)
Urinary CC16 rate
Measured: at day 1
SP-D rates
Measured: at day 1
sRAGE rates
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André LABBE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984046
- Sponsor's protocol ID
- CHU-0294
- Other IDs
- 2015-A01587-42
- Acronym
- CC16
- Status last verified
- Dec 2016
- First submitted
- 28 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Bronchiolitis and Severity Markers: Interest in Protein CC16
- ClinicalTrials.gov ID
- NCT02984046
- Acronym / sponsor ID
- CC16 / CHU-0294
- Conditions
- Acute Bronchiolitis
- Keywords
- Acute bronchiolitis, RSV, CC16, SP-D, sRAGE, Severity, Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute bronchiolitis | Experimental | Drug: Protein CC16Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants under 1 year old hospitalized for acute bronchiolitis
Key exclusion criteria (7 listed)
- Broncho dysplasia
- Preterm under 34 weeks
- Cystic fibrosis
- Immune deficiency
- Suspicion of primary ciliary dyskinesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein CC16 | Drug | acute bronchiolitis |
Primary outcome
Serum CC16 rate
Time frame: at day 1
3 secondary outcomes
Urinary CC16 rate
Time frame: at day 1
SP-D rates
Time frame: at day 1
sRAGE rates
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André LABBE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein CC16 in people with Acute Bronchiolitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CC16 rate (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.