Cystic FibrosisMUCOVIRNCT03736096
Molecular Diagnosis of Respiratory Viral Infections on Sputum From Cystic Fibrosis Patients
An observational study of Cystic Fibrosis and Acute Respiratory Infection, run by University Hospital, Brest at 11 sites in France.
Trial summary
The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis, Acute Respiratory Infection
- How many people
- 115 participants
- Where
- 11 sitesFrance
- Study dates
- 3 Oct 2018to 24 Jun 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: participant living with Cystic Fibrosis disease presenting an acute respiratory infection cared in french pediatric or adult Center
Who may be able to join
- participant with Cystic Fibrosis
- participant with sign of acute respiratory infection
- participant able to expectorate
Who cannot join
- participant not able to expectorate
- participant refusing to participate
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU d'ANGERS
Angers, 49033
CHU de CAEN
Caen, 14700
CHU de NANTES
Nantes, 44000
AP-HP - Hôpital TROUSSEAU
Paris, 75012
CHRU de Rennes
Rennes, 35033 Cedex 09
Centre de PERHARIDY
Roscoff, 29684
Hôpital FOCH
Suresnes, 92151
CHU Toulouse CRCM Pediatrique
Toulouse, 31059 Cedex 9
CHU Toulouse CRCM Adulte
Toulouse, 31059
CHU Tours
Tours, 37000
CHU de Tours
Tours, 37044
About this study
Official title: Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis
The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.
Read the detailed description
Viral respiratory infections in cystic fibrosis (CF) have a significant impact on the progression of the disease. It is therefore essential to look for these viruses. No recommendations are made for the virological follow-up of CF patients and no optimal strategy for the type of sampling required. In non-CF patients, the search for a viral infection is performed by nasopharyngeal sampling. This method of sampling is invasive and uncomfortable for the patient. In CF patients, sputum, non-invasive sampling, is routinely used for bacterial research and may be used for viral infections to avoid invasive nasopharyngeal sampling in patients whose management is heavy.
After giving consent, both sputum and nasopharyngeal swab are collected for each participant. A record of clinical and biological data is also made at inclusion. A molecular viral search is performed on both samples by a multiplex technique detecting a broad spectrum of respiratory viruses. A bacteriological analysis is carried out on sputum. The molecular results will be interpreted blindly according to the main criterion of evaluation, presence or absence of viral infection.
Comparison of expectoration to nasopharyngeal sampling of CF patients for respiratory virological diagnosis should analyse agreement of the molecular viral detection and position CF sputum as an optimal assay for respiratory viruses with the advantage of not being invasive and in all cases routinely taken for the control and bacterial follow-up.
The promotion of sputum as an ad hoc sampling for viral research and epidemiology would facilitate the establishment of surveillance for viral infections in cystic fibrosis and thereby contribute to the CF register data.
- Conditions
- Cystic Fibrosis, Acute Respiratory Infection
- Keywords
- cystic fibrosis, sputum, nasopharyngeal swab, viral molecular diagnosis, respiratory infection, expectoration
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab
Comparison of per participant results of viral molecular detection in both sputum and nasapharyngeal samples: 18 different types of respiratory viruses may be qualitatively detected by Molecular analyses (multiplex PCR) the Outcome Measure results will be reported as number of participants with same virus type in both sample - number participant with different virus detected in the two samples - number of participants with no virus detected in both samples - number of participants with one virus detected in nasapharyngeal and no virus in sputum - number of participant with no virus detected in nasopharyngeal and one virus detected in sputum - and so on for every possible combinations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start3 Oct 2018
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
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 University Hospital, BrestThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie VALLET, MD, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736096
- Sponsor's protocol ID
- MUCOVIR (2017-A02380-53)
- Acronym
- MUCOVIR
- Status last verified
- Jan 2023
- First submitted
- 5 Nov 2018
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03736096
- Acronym / sponsor ID
- MUCOVIR / MUCOVIR (2017-A02380-53)
- Conditions
- Cystic Fibrosis, Acute Respiratory Infection
- Keywords
- cystic fibrosis, sputum, nasopharyngeal swab, viral molecular diagnosis, respiratory infection, expectoration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- 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.
The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.
Detailed description
Viral respiratory infections in cystic fibrosis (CF) have a significant impact on the progression of the disease. It is therefore essential to look for these viruses. No recommendations are made for the virological follow-up of CF patients and no optimal strategy for the type of sampling required. In non-CF patients, the search for a viral infection is performed by nasopharyngeal sampling. This method of sampling is invasive and uncomfortable for the patient. In CF patients, sputum, non-invasive sampling, is routinely used for bacterial research and may be used for viral infections to avoid invasive nasopharyngeal sampling in patients whose management is heavy.
After giving consent, both sputum and nasopharyngeal swab are collected for each participant. A record of clinical and biological data is also made at inclusion. A molecular viral search is performed on both samples by a multiplex technique detecting a broad spectrum of respiratory viruses. A bacteriological analysis is carried out on sputum. The molecular results will be interpreted blindly according to the main criterion of evaluation, presence or absence of viral infection.
Comparison of expectoration to nasopharyngeal sampling of CF patients for respiratory virological diagnosis should analyse agreement of the molecular viral detection and position CF sputum as an optimal assay for respiratory viruses with the advantage of not being invasive and in all cases routinely taken for the control and bacterial follow-up.
The promotion of sputum as an ad hoc sampling for viral research and epidemiology would facilitate the establishment of surveillance for viral infections in cystic fibrosis and thereby contribute to the CF register data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participant living with Cystic Fibrosis disease presenting an acute respiratory infection cared in french pediatric or adult Center
Key inclusion criteria (3 listed)
- participant with Cystic Fibrosis
- participant with sign of acute respiratory infection
- participant able to expectorate
Key exclusion criteria (2 listed)
- participant not able to expectorate
- participant refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab
Time frame: Day 1
Comparison of per participant results of viral molecular detection in both sputum and nasapharyngeal samples: 18 different types of respiratory viruses may be qualitatively detected by Molecular analyses (multiplex PCR) the Outcome Measure results will be reported as number of participants with same virus type in both sample - number participant with different virus detected in the two samples - number of participants with no virus detected in both samples - number of participants with one virus detected in nasapharyngeal and no virus in sputum - number of participant with no virus detected in nasopharyngeal and one virus detected in sputum - and so on for every possible combinations
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 18 Jan 2023.
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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.
Sophie VALLET, MD principal investigator
CHU Brest
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Acute Respiratory Infection, run by University Hospital, Brest at 11 sites 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 3 inclusion and 2 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab (time frame: 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 18 Jan 2023.