Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections in Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Respiratory Infection

• Registration Number: NCT03684759
• Lead Sponsor: University Hospital, Brest

Brief Summary

The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

Detailed Description

In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs.

This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.

Study Timeline

• Study Start: 2016-02-24
• Primary Completion: 2017-02-06
• Study Completion: 2017-02-06
• Status Verified: 2018-09
• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• participant not able to expectorate
• patient refusing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 sputum and nasopharyngeal swab.; Concordance=same virus(es) or no virus detected in both sample. no concordance=different viruses detected in each sample or virus(es) detected in only one sample and not in the other

Trial Locations

Locations (3)

CHU d'Angers; 🇫🇷 Angers, France

Centre de Perharidy; 🇫🇷 Roscoff, France

Hôpital Foch; 🇫🇷 Suresnes, France