Condition category
Infections and Infestations
Date applied
30/06/2015
Date assigned
06/11/2015
Last edited
06/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Viral respiratory tract infections (i.e. viral infections of the sinuses, throat, airways or lungs) are a significant burden on the NHS particularly during the annual winter influenza epidemic. Most cases are managed either by the patient's GP's or in the Emergency Department (ED). GP’s surgeries and EDs, where patients are seen for a short time only, don't have timely access to diagnostic tests for respiratory viruses. The diagnosis is therefore a clinical one and where there is doubt, a number of these infections will be managed with unnecessary antibiotics in order to treat potential, undiagnosed bacterial infection. A proportion of all cases will also require hospital admission, wirh the patient having to be placed in isolation in a neutral or negative pressure side room. In one study, respiratory viruses were found to be responsible for 12.8% of patients with community acquired pneumonia (CAP) admitted to hospital in the UK. If undiagnosed and unisolated in the hospital, there is the potential for affected patients to pass the infection to others in the hospital (cross-transmission) which can lead to outbreaks of infection in a ward or even the hospital as a whole. As respiratory virus infections can affect staff as well as patients, the extreme consequences of unisolated cases are ward closures, and an increase in the number of people becoming ill or even dying. Mycoplasma pneumoniae and Chlamydophila pneumoniae (atypical pathogens) and Bordetella pertussis ('pertussis' or 'whooping cough') respiratory tract infections are often diagnosed clinically while waiting for laboratory results to come back, which take days. Laboratory tests don’t always perform well. Again, patients may be unnecessarily prescribed antibiotics and/or admitted to hospital. Increase illness and death rates may result from missed diagnoses. Providing a result for the detection of respiratory viruses, Mycoplasma, Chlamydophila & Pertussis in the Medical Admission when the patient is first seen, using point of care testing may avoid the issues highlighted, provide better quality of care, allow for better use of resources and reduce inappropriate antibiotic use and the development of antibiotic resistance. The aim of this study is to find out whether rapidly diagnosing whether an infection is caused by the any of the respiratory viruses, Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis at point of care in the Medical Admissions Units reduces unnecessary antibiotic use and length of hospital stay when compared to standard routine laboratory based tests.

Who can participate?
Patients aged at least 16 with a acute upper respiratory tract infection.

What does the study involve?
Participants are randomly allocated into one of two groups. Combined nose and throat swabs for standard respiratory virus testing are taken for patients in group 1 (control group). Combined nose and throat swabs for respiratory virus testing with the point of care PCR test are taken for patients in group 2. The two types of tests are then assessed by looking at, among other things, antibiotic use and length of hospital stay for all patients taking part in the study.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
King's College Hospital NHS Foundation Trust (UK)

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

Who is funding the study?
Biomerieux (UK)

Who is the main contact?
Dakshika Jeyaratnam

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dakshika Jeyaratnam

ORCID ID

Contact details

King's College Hospital London
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Point of care testing for respiratory pathogens

Acronym

RESP MAU POCT

Study hypothesis

To determine whether or not a rapid result for respiratory viruses, Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis at point of care in the Medical Admissions Units reduces unnecessary antibiotic use and length of hospital stay when compared to standard routine laboratory based tests.

Ethics approval

NRES Committee London - Westminster, 17/11/2014, ref: 14/LO/1703

Study design

Interventional single centre study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Rapid PCR-based diagnostic test when placed at the point of care

Intervention

1. Control: combined nose and throat swabs for respiratory virus testing with the laboratory -based PCR testing +/- atypical investigations e.g. serology
2. Intervention: combined nose and throat swabs for respiratory virus testing with the point of care PCR test

Intervention type

Device

Phase

Drug names

Primary outcome measures

Antibiotic use and length of hospital stay

Secondary outcome measures

1. Turnaround time of tests
2. Readmission rate
3. Mortality
4. Ease of use of Point of Care Test
5. Cost benefit

Overall trial start date

05/01/2015

Overall trial end date

01/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. ≥ 16 years of age
2. Have mental capacity to give written informed consent to participate in the study
3. Have acute upper respiratory tract infection or influenza-like illness +/- lower respiratory tract infection. Symptoms include fever or feeling feverish (chills), cough, sore throat, runny or stuffy nose, muscle-aches or body-aches, headaches, fatigue (tiredness), some people may have vomiting or diarrhoea (though this is more common in children than adults). Please note that not all patients with influenza have fever.

Please note that patients with a clinical or radiological diagnosis of community-acquired lower respiratory tract infection, evidence/suspicion of bacterial infection with common, ‘typical’ respiratory tract pathogens, patients with known or suspected immune suppression, and those with sepsis or severe sepsis are also eligible for inclusion.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2262

Participant exclusion criteria

1. Those who do NOT meet the inclusion criteria
2. Evidence/suspicion of bacterial infection affecting sites other than the respiratory tract

Recruitment start date

05/01/2015

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Cheyne Wing Bessemer Road Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital

Sponsor details

Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Biomerieux (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CLAHRC South London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes