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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03684759
Acronym
EXPIRE
Enrollment
30
Registered
2018-09-26
Start date
2016-02-24
Completion date
2017-02-06
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Respiratory Infection

Keywords

Expectoration, Cystic Fibrosis, Nasopharyngeal, Viral molecular diagnosis

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swabDay 1Comparison 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026