Condition category
Respiratory
Date applied
24/12/2014
Date assigned
14/01/2015
Last edited
27/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Respiratory viruses, including the influenza virus, cause large numbers of people to become unwell and be admitted to hospital every winter. The current diagnostic tests for respiratory viruses are done in laboratories away from patients and are time consuming, taking more than 24 hours to generate a result for doctors. New rapid tests for respiratory viruses have been developed that can be done in admission units and give results within 1 hour. These tests have equivalent accuracy to the standard laboratory tests and are licensed for clinical use in Europe and the USA. Introducing these new tests to admission units might improve the identification and management of patients infected with respiratory viruses and could also improve infection control practices to stop the spread of viruses within hospitals. Identifying viruses at an early stage of a patient’s care might also lead to a reduction in antibiotic use, which is important in reducing the spread of antibiotic resistance in hospitals. These changes might lead to an overall reduction in the costs for the National Health Service and its institutions. The aim of this study is to assess whether a test can improve people’s health, help them take fewer antibiotics and help them be less likely to end up in hospitals.

Who can participate?
Patients with a respiratory infection caused by viruses

What does the study involve?
Patients presenting to a hospital with respiratory illness will be randomly assigned to have a rapid test for respiratory viruses in addition to standard care or to standard care alone.

What are the possible benefits and risks of participating?
Improvement in clinical care, reduction in antibiotic use and reduction in the cost of hospital admissions

Where is the study run from?
University Hospitals Southampton Foundation NHS Trust (UK)

When is the study starting and how long is it expected to run for?
January 2015 to December 2016

Who is funding the study?
University of Southampton, Faculty of Medicine (UK)

Who is the main contact?
Dr Tristan Clark

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tristan Clark

ORCID ID

http://orcid.org/0000-0001-6026-5295

Contact details

LF101
Level F
South Academic Block
University Hospitals Southampton
tremona Road
Southampton.
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHM MED 1217

Study information

Scientific title

Comparison of point-of-care testing for respiratory viruses with standard clinical care in adults presenting to secondary care with acute respiratory illness (ResPOC): a randomised controlled study

Acronym

ResPOC

Study hypothesis

Point-of-care testing for respiratory viruses in adults hospitalised with acute respiratory illness might reduce antibiotic use, improve use of influenza treatments, improve use of isolation facilities and might reduce overall costs of hospitalisation compared with standard clinical care.

Ethics approval

National Research Ethics Service Committee North West - Preston (UK), 5 December 2014, REC reference: 14/NW/1467
Substantial amendments approved 09/07/2015 and 02/02/2016.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Adults presenting to secondary care with acute respiratory illness

Intervention

Participants are enrolled and assigned a study number consequently. Patients are randomised 1:1 to the intervention or control groups using an online randomisation service (sealed envelope.com). Blinding is not attempted.

Intervention group: A nose and throat swab will be taken by a member of research staff (doctor or nurse) according to standard protocols. Swabs are placed directly into viral transport medium. The sample is analysed on the FilmArray Respiratory Panel as per training delivered by the apparatus manufacturer. Test results are normally available within 1 hour using the FilmArray Respiratory Panel. In the event of a run failure, the analysis run will be repeated using the same sample.
The results of the test will be documented in the patient’s case notes and in the event of a pathogen being detected, a doctor from the clinical team responsible for the patient will be directly informed. The participant will also be informed of the result on the same day.

Control:
These patients will be managed using standard clinical care. Respiratory virus testing using lab RT-PCT will be at the discretion of the responsible clinical team.

There is no follow up for study participants. Outcomes are collected retrospectively from case notes for the entire duration of hospitalisation or at 30 days, whichever is shortest.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Proportion of patients treated with antibiotics: measured retrospectively from case notes for the entire duration of hospitalisation or at 30 days, whichever is shortest

Secondary outcome measures

Secondary outcome measures as of 27/09/2016:
The outcomes will be measured retrospectively from case notes for the entire duration of hospitalisation or at 30 days, whichever is shortest.
1. Duration of antibiotic use
2. Proportion of patients receiving only a stat dose of antibiotics
3. Proportion of patients receiving <48 hours antibiotics
4. Proportion of patients treated with antiviral drugs
5. Time to antiviral drug use
6. Duration of antiviral drugs
7. Duration of hospital stay
8. Proportion of patients nursed in a side room
9. Duration of side room use
10.Time to allocation of a side room
11. Health care utilisation

Original secondary outcome measures:
The outcomes will be measured retrospectively from case notes for the entire duration of hospitalisation or at 30 days, whichever is shortest.
1. Duration of antibiotic use
2. Proportion of patients treated with antiviral drugs
3. Time to antiviral drug use
4. Duration of antiviral drugs
5. Duration of hospital stay
6. Proportion of patients seen by a nurse in a side room
7. Time to allocation to a side room
8. Number of investigations done

Overall trial start date

01/01/2015

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years old or over
2. Capacity to provide written informed consent and is able and willing to adhere to the study procedures
3. Is a patient at Southampton General Hospital Acute Medical Unit (AMU) or Emergency Department (ED)
4. Can be recruited to the study within 24 hours of first triage by ED staff or within 24 hours of arrival on AMU (if admitted directly to AMU)
5. Has an acute respiratory illness and/or fever >37.5°C
6. Duration of illness less than or equal to 7 days

An episode of acute respiratory illness is defined as an acute pulmonary illness (including pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of chronic obstructive pulmonary disease, asthma or bronchiectasis).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

720

Participant exclusion criteria

1. A palliative approach is being taken by the treating clinicians
2. Previously included in this study (first season only)
3. Declines nasal or pharyngeal swabbing

Recruitment start date

15/01/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Southampton Foundation NHS Trust
University Hospitals Southampton, Tremona Road, Southampton
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hopsital Southampton Foundation NHS Trust

Sponsor details

Research and Development department. Level E Pathology Block
SCBR Mailpoint 138
Southampton General Hospital
University Hospitals Southampton
tremona Road
Southampton.
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Southampton, Faculty of Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will be disseminated locally and nationally and submitted for publication to a clinical infectious diseases or respiratory journal.

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/09/2016: The trial record has undergone an extensive update as it has changed from a pilot study to an internal pilot of a larger full study (following ethical approval of substantial amendments). The following changes have been made: 1. The public title has been updated (originally: "A preliminary comparison of point-of-care testing for respiratory viruses with standard clinical care in adults with respiratory illness") 2. The scientific title has been updated (originally: "Comparison of point-of-care testing for respiratory viruses with standard clinical care in adults presenting to secondary care with acute respiratory illness (ResPOC): a randomised controlled, pilot study") 3. The dates of ethical amendments have been added 4. The target number of participants have been updated from 400 to 720 5. The secondary outocme measures have been updated 6. The overall trial end date has been updated from 30/04/2016 to 31/12/2016 7. Information about the randomisation process and what the study arms involve has been added to the interventions section.