Novel Technologies for Respiratory Virus Identification

NCT05661032 | Recruiting

• 1 other identifier: PHU/2022/64
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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 Pictura Bio 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 Pictura Bio 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.

Conditions

Infections, Respiratory; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (2)

• The Pictura Bio system to detect viral pathogens from human derived samples

  To determine whether the Pictura Bio system is able to detect viral pathogens from human derived samples compared with gold standard methodologies used in NHS diagnostic settings

  Until 01/03/2026

• Create a fluorescent based viral data pattern database

  To create a fluorescent based viral data pattern database from human samples which can be used to interrogate machine learning algorithms to improve sensitivity and specificity for continued development of the technology

  Until 01/03/2026

Secondary Outcomes (2)

• The prevalence of seasonal respiratory viruses in the local hospital community

  Until 01/03/2026

• Prevalence use of antibiotics for respiratory infections

  Until 01/03/2026

Study Arms (2)

Covid Positive

Nasopharyngeal Swab

Covid Negative

Nasopharyngeal Swab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Anybody with a suspected or confirmed respiratory virus illness (including both staff and patients)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Sharon Glaysher, Dr

  Portsmouth University Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvette Hibberd

CONTACT

023 9228 6000; Yvette.hibberd@porthosp.nhs.uk

Joe Shoebridge

CONTACT

023 9228 6000; joe.shoebridge@porthosp.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 22, 2022
• Study Start: January 18, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

GB (1)