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Completed

NCT Number: NCT03684759

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: EXPIRE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2018
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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