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NCT05661032
Novel Technologies for Respiratory Virus Identification
Conditions: Infections, Respiratory, Respiratory Tract Infections
Sex: All
Enrollment: 1000
Sponsor: Portsmouth Hospitals NHS Trust
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 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.
Eligibility Criteria
Inclusion Criteria:Provide informed, (parental/guardian, where appropriate) consentAble 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 coughSore throatHead and/or Muscle achesFever or chillsExclusion Criteria:Unable to comply with study procedures or where in the opinion of the investigator, undertaking a nasopharyngeal swab may be detrimental to the individualLacking capacity to consent
Source: ClinicalTrials.gov (NCT05661032). StuddyBuddy aggregates publicly available trial information.