We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03736096 | Cystic Fibrosis
Previous Study | Return to List | Next Study

Molecular Diagnosis of Respiratory Viral Infections on Sputum From Cystic Fibrosis Patients (MUCOVIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03736096
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : January 18, 2023
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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). 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.

Condition or disease
Cystic Fibrosis Acute Respiratory Infection

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis
Actual Study Start Date : October 3, 2018
Actual Primary Completion Date : June 24, 2021
Actual Study Completion Date : June 24, 2021

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples With DNA
sputum and nasopharyngeal swab from expectorant CF participants retained at -80°C

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participant living with Cystic Fibrosis disease presenting an acute respiratory infection cared in french pediatric or adult Center

Inclusion Criteria:

  • participant with Cystic Fibrosis
  • participant with sign of acute respiratory infection
  • participant able to expectorate

Exclusion Criteria:

  • participant not able to expectorate
  • participant refusing to participate

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): NCT03736096

Layout table for location information
Angers, France, 49033
Caen, France, 14700
Nantes, France, 44000
Paris, France, 75012
CHRU de Rennes
Rennes, France, 35033 Cedex 09
Roscoff, France, 29684
Hôpital FOCH
Suresnes, France, 92151
CHU Toulouse CRCM Pediatrique
Toulouse, France, 31059 Cedex 9
CHU Toulouse CRCM Adulte
Toulouse, France, 31059
CHU Tours
Tours, France, 37000
CHU de Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Brest
Layout table for investigator information
Principal Investigator: Sophie VALLET, MD CHU Brest
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03736096    
Other Study ID Numbers: MUCOVIR (2017-A02380-53)
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
cystic fibrosis
nasopharyngeal swab
viral molecular diagnosis
respiratory infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases