Novel Technologies for Respiratory Virus Identification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPortsmouth Hospitals NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide informed, (parental/guardian, where appropriate) consent

Able to provide nasopharyngeal swab/aspirate specimens.

Coryzal symptoms (runny nose, sneezing and/or nasal congestion)

New onset of cough

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Covid Positive
Group B: Covid Negative

Trial outcomes

Primary outcomes

1

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

Time frame
Until 01/03/2026
2

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

Time frame
Until 01/03/2026

Secondary outcomes

1

The prevalence of seasonal respiratory viruses in the local hospital community

Observe the prevalence of seasonal respiratory viruses in the local hospital community following the lifting of previous COVID restrictions to help direct future local IPC guidelines

Time frame
Until 01/03/2026
2

Prevalence use of antibiotics for respiratory infections

Observe the use of antibiotics for respiratory infections to help understand prescribing patterns and any over or under use

Time frame
Until 01/03/2026

Other outcomes

Sponsors and contacts

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