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

Cystic Fibrosis Clinical Trial

— MUCOVIR  

Official title:

Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736096
• Other study ID #: MUCOVIR (2017-A02380-53)
• Status: Completed
• Start date: October 3, 2018
• Est. completion date: June 24, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Cystic Fibrosis
• Fibrosis
• Infections
• Respiratory Tract Infections
• Virus Diseases

Locations

Country	Name	City	State
France	CHU d'ANGERS	Angers
France	CHU de CAEN	Caen
France	CHU de NANTES	Nantes
France	AP-HP - Hôpital TROUSSEAU	Paris
France	CHRU de Rennes	Rennes
France	Centre de PERHARIDY	Roscoff
France	Hôpital FOCH	Suresnes
France	CHU Toulouse CRCM Adulte	Toulouse
France	CHU Toulouse CRCM Pediatrique	Toulouse
France	CHU de Tours	Tours
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1