Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens (NCT04431050) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens
Stopped: Terminated due to covid-19- not reinstated due to low flu admissions
United Kingdom6 participantsStarted 2020-02-21
Plain-language summary
This study evaluates a single use point of care diagnostic test in the diagnosis of influenza and other respiratory viral infections in adults. Participants will have a sample taken from their nose using a swab. The swab will be gently mixed in a liquid solution which will then be transferred into the device for testing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Any adult ≥18 years of age presenting to the A+E department with ILI or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated and who is:
* Able to provide written informed consent, or written informed assent by a relative or carer
* Recruited during initial medical assessment
* Able to comply with the study protocol
Exclusion Criteria:
* Previously recruited within 28 days of the current admission
* Enrolment in a trial of antimicrobial therapy
* If patients are unable to understand verbal or written information in English, hospital translation services will be sought but not guaranteed. However, if the team member seeking consent is not satisfied that the potential recruits' English language ability is sufficient to completely understand the study protocol and requirements (despite use of hospital translation services) then they will not be recruited to the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing the Feasibility of a Single Use Diagnostic Point of Care Test Against Standard Care Testing Methods, in a Real-life Clinical Setting.
Timeframe: through study completion, an average of 1.5 years