NCT03684759

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Respiratory Infection

Timeline

• Start date: 2016-02-24
• Primary completion: 2017-02-06
• Completion: 2017-02-06
• First posted: 2018-09-26
• Last updated: 2018-09-26

Locations

3 sites across 1 country: France