R-POCT RCT: COPD exacerbations
Research type
Research Study
Full title
Feasibility study of a randomised controlled trial to investigate the effectiveness of a rapid point of care testing panel for respiratory viruses (R-POCT) in improving antibiotic prescribing and reducing acute hospital admission in patients identified with an exacerbation of chronic obstructive pulmonary disease (COPD) in the community.
IRAS ID
252568
Contact name
Kay Roy
Contact email
Sponsor organisation
CLCH
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Patients with chronic obstructive pulmonary disease (COPD) can experience an acute deterioration (‘exacerbation’) if they develop chest infections. Identifying the kind of infection (viral versus bacterial) typically takes at least a few days. This delay can lead to antibiotic treatment or hospital admission that might have been avoided if a definitive diagnosis of the type of infection was made more rapidly.
Hence a tool allowing earlier diagnosis of infection should help COPD patients receive better care and reduce unnecessary NHS expenditure, as well as combating antibiotic resistance by reducing inappropriate prescribing.
Our study will evaluate the impact of using community rather than laboratory/hospital based machines to rapidly rule-in or rule-out all common types of respiratory viral infection, from a nasal swab and testing blood samples to assess exacerbation severity and whether it is likely to be bacterial in origin.
COPD patients under our community respiratory service who experience an exacerbation will be randomised to either
a) standard clinical care, or
(b) POCT-guided care.Management in the standard care arm will include nurse-led review at home and antibiotic treatment. Nasal swabs and blood tests will be analysed but not used to guide treatment.
In the POCT arm, patients will likewise be seen at home and nasal swabs taken. However these swabs will be transported urgently to a ‘community hub’ site for processing on the respiratory viral machine. Results will be available after approximately one hour. Antibiotic treatment may be withheld if a positive viral diagnosis is made.
A blood sample will also be taken in the POCT arm and assessment here of markers of inflammation will help evaluate exacerbation severity, type of infection and guide clinical decisions.Patients are followed-up for 3 months for events including hospital admission and results will guide a larger study for the future.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0678
Date of REC Opinion
23 Dec 2018
REC opinion
Unfavourable Opinion