Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens

NCT04431050 | Terminated Results

• 1 other identifier: 19SM5486
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Influenza; Respiratory Syncytial Virus Infections; Rhinoviral Infections; Enterovirus Infections; Metapneumovirus Infection; Parainfluenzae Viral Infections

Outcome Measures

Primary Outcomes (1)

• Assessing the Feasibility of a Single Use Diagnostic Point of Care Test Against Standard Care Testing Methods, in a Real-life Clinical Setting.

  The primary outcome will be to review the feasibility and the diagnostic accuracy for viral respiratory pathogens in this novel device using fresh patients' samples in a real-life clinical setting compared to the standard diagnostic testing of a respiratory viral PCR in the laboratory and/or rapid flu swab (Cepheid, Sunnyvale, CA, USA) using sensitivity, specificity, positive predictive value and negative predictive values. A minimum of 50 devices will be tested with fresh patient samples in a real life clinical setting.

  through study completion, an average of 1.5 years

Secondary Outcomes (1)

• To Compare the Results Obtained in a Clinical Setting to the Analytical Study Data and Laboratory Tests on Stored Samples.

  through study completion, an average of 1.5 years

Study Arms (1)

Suspected influenza or other respiratory viral infection.

Any adult presenting to the Accident \& Emergency department with influenza like illness or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated. For the purposes of this study one nasal swab will be taken from consenting adults.

Diagnostic Test: Point of care testing of respiratory viruses.

Interventions

Point of care testing of respiratory viruses. DIAGNOSTIC_TEST

Single use point of care diagnostic device.

Suspected influenza or other respiratory viral infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any consenting adult presenting to the Accident and Emergency department with influenza like illness or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated will be recruited.

You may qualify if:

• 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

You may not qualify 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.

Sponsors & Collaborators

• Imperial College London: lead
• Sense Biodetection Limited: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One nasal swab taken from each participant for diagnostics.

MeSH Terms

Conditions

Influenza, Human; Respiratory Syncytial Virus Infections; Enterovirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Picornaviridae Infections

Results Point of Contact

• Title: Joan Nanan
• Organization: Imperial

j.nanan@imperial.ac.uk

+44 (0)20 7594 9000

Study Officials

• David Muir

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: June 16, 2020
• Study Start: February 21, 2020
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-01

Locations

GB (1)