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NCT Number: NCT03736096

Molecular Diagnosis of Respiratory Viral Infections on Sputum From Cystic Fibrosis Patients

The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.

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Key information

Conditions

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

Viral respiratory infections in cystic fibrosis (CF) have a significant impact on the progression of the disease. It is therefore essential to look for these viruses. No recommendations are made for the virological follow-up of CF patients and no optimal strategy for the type of sampling required. In non-CF patients, the search for a viral infection is performed by nasopharyngeal sampling. This method of sampling is invasive and uncomfortable for the patient. In CF patients, sputum, non-invasive sampling, is routinely used for bacterial research and may be used for viral infections to avoid invasive nasopharyngeal sampling in patients whose management is heavy.

After giving consent, both sputum and nasopharyngeal swab are collected for each participant. A record of clinical and biological data is also made at inclusion. A molecular viral search is performed on both samples by a multiplex technique detecting a broad spectrum of respiratory viruses. A bacteriological analysis is carried out on sputum. The molecular results will be interpreted blindly according to the main criterion of evaluation, presence or absence of viral infection.

Comparison of expectoration to nasopharyngeal sampling of CF patients for respiratory virological diagnosis should analyse agreement of the molecular viral detection and position CF sputum as an optimal assay for respiratory viruses with the advantage of not being invasive and in all cases routinely taken for the control and bacterial follow-up.

The promotion of sputum as an ad hoc sampling for viral research and epidemiology would facilitate the establishment of surveillance for viral infections in cystic fibrosis and thereby contribute to the CF register data.

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 with sign of acute respiratory infection
  • participant able to expectorate

Exclusion criteria

  • participant not able to expectorate
  • participant 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 both sputum and nasapharyngeal samples: 18 different types of respiratory viruses may be qualitatively detected by Molecular analyses (multiplex PCR) the Outcome Measure results will be reported as number of participants with same virus type in both sample - number participant with different virus detected in the two samples - number of participants with no virus detected in both samples - number of participants with one virus detected in nasapharyngeal and no virus in sputum - number of participant with no virus detected in nasopharyngeal and one virus detected in sputum - and so on for every possible combinations

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis

Acronym: MUCOVIR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2018
Registry last updated
Jan 18, 2023

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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