NCT05661032 Novel Technologies for Respiratory Virus Identification
| NCT ID | NCT05661032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Portsmouth Hospitals NHS Trust |
| Condition | Infections, Respiratory |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-01-18 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sharon Glaysher, Dr
PRINCIPAL INVESTIGATOR
Portsmouth University Hospital NHS Trust
Frequently Asked Questions
Who can join the NCT05661032 clinical trial?
This trial is open to participants of all sexes, studying Infections, Respiratory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05661032 currently recruiting?
Yes, NCT05661032 is actively recruiting participants. Contact the research team at Yvette.hibberd@porthosp.nhs.uk for enrollment information.
Where is the NCT05661032 trial being conducted?
This trial is being conducted at Portsmouth, United Kingdom.
Who is sponsoring the NCT05661032 clinical trial?
NCT05661032 is sponsored by Portsmouth Hospitals NHS Trust. The principal investigator is Sharon Glaysher, Dr at Portsmouth University Hospital NHS Trust. The trial plans to enroll 1,000 participants.