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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Acute upper respiratory infectionsInfluenza and pneumoniaOther diseases of upper respiratory tract
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This is a prospective single centre feasibility study in the accident and emergency (A+E) department of Imperial College Healthcare NHS Trust (ICHNT) in patients presenting with influenza like illness (ILI).
The primary objective is to assess the feasibility of this single use device for the diagnosis of influenza and other respiratory pathogens in upper airway samples at the point of care (POC) in a real-life setting and compare the results against the conventional laboratory diagnostic methods of Polymerase Chain Reaction (PCR) testing. Further objectives are to compare the results to the analytical study data and laboratory test on stored samples as well as develop a bank of samples for further testing of the device in laboratory conditions.
One nasal swab to be taken per patient recruited in addition to the swab(s) (nasal, nasopharyngeal or throat swab) taken for standard care. Routine sample(s) (A) to be processed for standard PCR testing in the laboratory and/or rapid flu testing (Cepheid, Sunnyvale, CA, USA) as per standard clinical work flow. Second sample (B) to be taken for evaluation under the study and either: (i) transferred to the new device buffer tube and promptly tested in a test device or (ii) if no device is available for prompt testing, add the swab to a viral storage/transport buffer tube as per standard procedures and freeze for long-term storage and later testing.
As this is a feasibility study, diagnostic standard of care tests should be performed as per the clinical pathway with routine sample(s) (A) and the results of the test devices should not affect clinical decisions and should not be disclosed to either the patient or the clinician.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of investigation /therapeutic procedures;
You can take part if:
You may not be able to take part if:
- 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 43906
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