The PneumEx Study
Research type
Research Study
Full title
The PneumEx Study: Experimental Human Pneumococcal Carriage and Exhaled Pneumococcal Biomarkers
IRAS ID
269714
Contact name
Andrea Collins
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The aim of this study is to assess if ‘BreathSpec’ and the ‘Exhaled Detection Facemask’ (EDF) are able to identify and quantify Streptococcus pneumoniae (pneumococcus) in exhaled breathe from participants who have had pneumococcus experimentally introduced into their nose.
Antimicrobial resistance is a growing problem all over the world. In order to address this, better diagnostic tests are urgently needed to improve our antibiotic use. Currently only 50-73% of patients with pneumonia have an underlying cause identified - this leads to poor antibiotic prescribing. This study uses two new diagnostic devices that we hope could identify the presence of the leading cause of pneumonia, Streptococcus pneumoniae. The first device, BreathSpec, analyses chemicals that are present in exhaled breath. We are looking for a specific ‘signature’ that indicates the presence of pneumococcus. The second, EDF, is a facemask that collects microbiology samples from exhaled breath, in order to advance our knowledge of how pneumonia is spread.
The ‘Experimental Human Pneumococcal challenge’ (EHPC) model allows us to perform both BreathSpec and EDF before and after the bacteria is experimentally introduced into a participant’s nose. As a result, we can use the two devices to assess the changes occurring when the bacteria is present.
Clinical trial plan is to perform BreathSpec (breathing into a machine) and EDF (wearing a facemask for half an hour) in 50 participants who have had pneumococcus put up their nose. Samples will then be collected intermittently for the following month.
The EHPC model has been used in over 1000 adults in Liverpool for the past nine years safely with no serious side effects (participants were required to report any symptoms to the clinical team). Both devices involved in the study collect samples from exhaled breath only.
In future these data may contribute to the development of devices that better identify the cause of pneumonia and guide targeted antibiotic treatment.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0586
Date of REC Opinion
16 Oct 2019
REC opinion
Favourable Opinion