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

Sponsor

University Hospital, Brest (Other)

Overall Status

Unknown status

CT.gov ID

NCT03736096

Collaborator

(none)

135

Enrollment

Locations

11.9

Anticipated Duration (Months)

19.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

135 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Validation du Diagnostic moléculaire Des Infections Virales Respiratoires Sur Les Expectorations Des Patients Atteints de Mucoviscidose Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis

Actual Study Start Date :

Oct 3, 2018

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Outcome Measures

Primary Outcome Measures

Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU d'ANGERS	Angers	France	49033
2	CHU de CAEN	Caen	France	14700
3	CHU de NANTES	Nantes	France	44000
4	AP-HP - Hôpital TROUSSEAU	Paris	France	75012
5	Centre de PERHARIDY	Roscoff	France	29684
6	Hôpital FOCH	Suresnes	France	92151
7	CHU de Tours	Tours	France	37044