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

Cystic Fibrosis Clinical Trial

— EXPIRE  

Official title:

Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684759
• Other study ID #: EXPIRE
• Status: Completed
• Start date: February 24, 2016
• Est. completion date: February 6, 2017

Study information

• Verified date: September 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 6, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	Centre de Perharidy	Roscoff
France	Hôpital Foch	Suresnes

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 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	Day 1