Breathspec study in Respiratory Tract Infections
Research type
Research Study
Full title
A multicentre prospective, observational, longitudinal cohort study in adult patients with suspected Upper or Lower Respiratory infection (URTI/LRTI) to identify a spectrum of biomarkers in exhaled breath to discriminate participants with bacterial RTI from participants without.
IRAS ID
234488
Contact name
Nicholas Feasey
Contact email
Sponsor organisation
LIVERPOOL SCHOOL OF TROPICAL MEDICINE
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
This multicentre prospective, observational, longitudinal cohort study aims to obtain chemical information of exhaled breath biomarker data from adult patients with suspected Upper and Lower Respiratory pathologies (URTI/LRTI) to support clinical decision making regarding the diagnosis and treatment of suspected RTI.
Patients with suspected RTI who consent to participate in the study will be asked to provide one complete breath sample directly into each of two different Breathspec® instruments by exhaling into a disposable mouthpiece for 3-5 seconds. Subjects will be asked to swill their mouth with water immediately before taking the test.
An ambient air sample will be collected after each breath sample. Analysis of a sample (breath or ambient air) will take less than 10 minutes. The participant does not need to be present for this analysis.
The results of the gas phase chemical analysis will be stored in the internal memory of each device for subsequent downloading and analysis.
Patients will be assessed and treated at the study sites as per best practice for the diagnosis and treatment of RTIs.REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/1029
Date of REC Opinion
25 Jun 2018
REC opinion
Further Information Favourable Opinion