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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29017451