Image

Novel Technologies for Respiratory Virus Identification

Novel Technologies for Respiratory Virus Identification

Recruiting
All
Phase N/A

Powered by AI

Overview

Current virus detection methods often take significant time or can be limited in sensitivity, specificity or cost. There is therefore a need for diagnostic methods that are simple to use, sensitive, rapid and inexpensive.

This is a proof of concept study to determine whether the OxDx system (a new a rapid pathogen identification technology) is able to detect and differentiate different viruses from nasopharyngeal swabs/aspirate specimens. The data collected will be used to "train" the algorithms to be able to accurately identify respiratory viruses. The accuracy with which the algorithms estimate the test dataset will be monitored at regular intervals during the training dataset collection period. The OxDx system is still under development, which means that it is still "learning". The system needs to see more information so that it can be sufficiently accurate to be used in clinical practice and should become more accurate in identifying these viruses as it sees more and more information from patients.

This study will take place at Portsmouth Hospitals University NHS Trust and aims to recruit 1000 patients. To do this, we will recruit both adults and children who either present to the emergency department or are admitted to QAH with a clinical suspicion of a respiratory viral infection. All participants will have a nose and/or throat swab taken as part of their clinical assessment, and we would ask to take a further nasal swab for the purpose of the study. Research sampling will be combined with routine clinical samples where possible to reduce the frequency of testing. We will use most of the information to teach the system how to become more accurate at identifying respiratory viruses. We will keep the remaining information separate and use it to test how accurate the system is. All of the data will be kept securely. Basic information will be collected including age, gender, results of blood tests taken for clinical review, treatment and outcome data. No results from the swabs taken for the purpose of the study will be available to either the participant or the clinical team and the information will have no effect on patient care.

Description

NHS services always come under pressure over the winter period as demand for hospital services increase with the arrival of cold weather and the increase spread of respiratory infections.

As hospitals now look beyond the COVID-19 pandemic, the need to meet future hospital service challenges are important. Changes in habit and measures put in place to control the spread of COVID-19 have affected the transmission of other respiratory viruses. Understanding changes in occurrences of respiratory like illnesses during the winter period could help in understanding future winter pressures for healthcare services.

Since viral and bacterial infection symptoms can be similar, broad spectrum antibiotics are often used as the first line of defence even when the cause of infection is unknown. Antibiotics are not effective against viral infections and only work against bacteria. Antibiotics prevent millions of deaths each year however, inappropriate prescription rates and overuse have led to antibiotic resistance that has created a global health emergency in superbugs resistant to these treatments. There is a need for rapid and sensitive tests to diagnose the cause of infection and ensure patients get the most suitable type of treatment.

THE TECHNOLOGY The hospital is working closely with OxDX, who are developing a rapid pathogen identification technology comprising microscope and a computer which is trained to recognise fluorescent patterns from different viruses. The performance of this technology computer is highly dependent on the quality of the samples used to train it. It has the potential to be quicker than current gold standard technology and could be used in a patient facing setting including GP surgeries and Pharmacies.

THE RESEARCH STUDY This is a proof of concept study to determine whether the OxDx system is able to detect and differentiate different viruses from nasopharyngeal swabs/aspirate specimens. The data collected will be used to "train" the algorithms to be able to accurately identify respiratory viruses. The accuracy with which the algorithms estimate the test dataset will be monitored at regular intervals during the training dataset collection period. The OxDx system is still under development, which means that it is still "learning". The system needs to see more information so that it can be sufficiently accurate to be used in clinical practice and should become more accurate in identifying these viruses as it sees more and more information from patients.

This study will take place at Portsmouth Hospitals University NHS Trust and aims to recruit 1000 patients. To do this, we will recruit both adults and children who either present to the emergency department or are admitted to QAH with a clinical suspicion of a respiratory viral infection. All participants will have a nose and/or throat swab taken as part of their clinical assessment, and we would ask to take a further nasal swab for the purpose of the study. Research sampling will be combined with routine clinical samples where possible to reduce the frequency of testing. We will use most of the information to teach the system how to become more accurate at identifying respiratory viruses. We will keep the remaining information separate and use it to test how accurate the system is. All of the data will be kept securely. Basic information will be collected including age, gender, results of blood tests taken for clinical review, treatment and outcome data. No results from the swabs taken for the purpose of the study will be available to either the participant or the clinical team and the information will have no effect on patient care.

SHARING OF FINDINGS Results of the study will be disseminated via paper submissions to relevant journals and conferences. A lay summary of the results will be produced in collaboration with the PHT PRA group. The study team will explore with this group other avenues and formats for the dissemination of the study findings to ensure as wide a public audience as possible, for example through co-produced public talks, articles in community communications and social media.

Eligibility

Inclusion Criteria:

  • Provide informed, (parental/guardian, where appropriate) consent
  • Able to provide nasopharyngeal swab/aspirate specimens.
  • A clinical suspicion of a respiratory viral infection with one or more of the following symptoms:
  • Coryzal symptoms (runny nose, sneezing and/or nasal congestion)
  • New onset of cough
  • Sore throat
  • Head and/or Muscle aches
  • Fever or chills

Exclusion Criteria:

  • Unable to comply with study procedures or where in the opinion of the investigator, undertaking a nasopharyngeal swab may be detrimental to the individual
  • Lacking capacity to consent

Study details
    Infections
    Respiratory
    Respiratory Tract Infections

NCT05661032

Portsmouth Hospitals NHS Trust

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.