A controlled clinical trial investigating the impact of point of care testing for ‘atypical’ pneumonia, bordetella pertussis and viral pathogens on patient pathways, antimicrobial consumption and cost-efficiency.
| ISRCTN | ISRCTN10470967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10470967 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/06/2015
- Registration date
- 06/11/2015
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
King's College Hospital London
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Study design | Interventional single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Point of care testing for respiratory pathogens |
| Study acronym | RESP MAU POCT |
| Study objectives | 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(s) | NRES Committee London - Westminster, 17/11/2014, ref: 14/LO/1703 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 05/01/2015 |
| Completion date | 01/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2262 |
| Key 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. |
| Key exclusion criteria | 1. Those who do NOT meet the inclusion criteria 2. Evidence/suspicion of bacterial infection affecting sites other than the respiratory tract |
| Date of first enrolment | 05/01/2015 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bessemer Road
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor information
Hospital/treatment centre
Denmark Hill
London
SE5 9RS
England
United Kingdom
"ROR" |
https://ror.org/01qz4yx77 |
|---|
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/10/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/10/2017: Publication reference added.
