Cystic FibrosisPREVIMUCNCT02847156
Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis.
A study testing Physical assessment in people with Cystic Fibrosis and Respiratory Viral Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Cystic Fibrosis, Respiratory Viral Infection
- What is being tested?
- Physical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2016
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infant <24 months with cystic fibrosis
Who cannot join
- patient >24 months
Trial locations and contacts
1 site in 1 country.
France1 site
Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon
Bron, 69677
About this study
Official title: Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.
The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.
Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.
- Conditions
- Cystic Fibrosis, Respiratory Viral Infection
- Being tested
- Physical assessment
- Keywords
- cystic fibrosis, viruses, respiratory viral infection, children
- Medical subject headings
- Cystic Fibrosis, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical assessmentOther
1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis infants | Other | 1 year follow-up in CF infants Receives: Other: Physical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Respiratory Viral Infection
Measured: up to 12 months
Secondary outcomes (6)
Identification of respiratory viruses in throat-swabs
A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.
Measured: up to 12 months
Number of antibiotics treatments (oral or IV)
Measured: up to 12 months
Number of bronchodilator administrations
Measured: up to 12 months
Number of corticosteroids administrations
Measured: up to 12 months
Number of hospitalization or hospital admission due to upper or lower RVI
Measured: up to 12 months
Identification of bacterial flora in throat-swabs
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie VRIELYNCK, MD, Principal investigator, Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847156
- Sponsor's protocol ID
- 69HCL14_0276
- Acronym
- PREVIMUC
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT02847156
- Acronym / sponsor ID
- PREVIMUC / 69HCL14_0276
- Conditions
- Cystic Fibrosis, Respiratory Viral Infection
- Keywords
- cystic fibrosis, viruses, respiratory viral infection, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jul 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.
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.
The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.
Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis infants | Other | Other: Physical assessment1 year follow-up in CF infants |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infant <24 months with cystic fibrosis
Key exclusion criteria (1 listed)
- patient >24 months
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 |
|---|---|---|
| Physical assessment1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments | Other | cystic fibrosis infants |
Primary outcome
Number of Respiratory Viral Infection
Time frame: up to 12 months
6 secondary outcomes
Identification of respiratory viruses in throat-swabs
Time frame: up to 12 months
Number of antibiotics treatments (oral or IV)
Time frame: up to 12 months
Number of bronchodilator administrations
Time frame: up to 12 months
Number of corticosteroids administrations
Time frame: up to 12 months
Number of hospitalization or hospital admission due to upper or lower RVI
Time frame: up to 12 months
Identification of bacterial flora in throat-swabs
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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.
Stéphanie VRIELYNCK, MD principal investigator
Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical assessment in people with Cystic Fibrosis and Respiratory Viral Infection, run by Hospices Civils de Lyon 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 1 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: finished, as of the sponsor's last update on 28 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Respiratory Viral Infection (time frame: up to 12 months). 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 28 Jul 2016.