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

NCT03736096 | Completed DMC

• 1 other identifier: MUCOVIR (2017-A02380-53)
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 11

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.

Conditions

Cystic Fibrosis; Acute Respiratory Infection

Keywords

cystic fibrosis; sputum; nasopharyngeal swab; viral molecular diagnosis; respiratory infection; expectoration

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• participant not able to expectorate
• participant refusing to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHU d'ANGERS

Angers, 49033, France

Location

CHU de CAEN

Caen, 14700, France

Location

CHU de NANTES

Nantes, 44000, France

Location

AP-HP - Hôpital TROUSSEAU

Paris, 75012, France

Location

CHRU de Rennes

Rennes, 35033 Cedex 09, France

Location

Centre de PERHARIDY

Roscoff, 29684, France

Location

Hôpital FOCH

Suresnes, 92151, France

Location

CHU Toulouse CRCM Pediatrique

Toulouse, 31059 Cedex 9, France

Location

CHU Toulouse CRCM Adulte

Toulouse, 31059, France

Location

CHU Tours

Tours, 37000, France

Location

CHU de Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

sputum and nasopharyngeal swab from expectorant CF participants retained at -80°C

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Infections

Study Officials

• Sophie VALLET, MD

  CHU Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: October 3, 2018
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

FR (11)