BALLOON study v1
Research type
Research Study
Full title
Proof-of-concept study to determine the feasibility of measuring bacterial load in exhaled breath of children with pneumonia and empyema using a novel point-of-care test.
IRAS ID
195143
Contact name
Colin Powell
Contact email
Sponsor organisation
Cardiff University
Clinicaltrials.gov Identifier
Bill and Melinda Gates Foudation, OPP1138589; School of Medicine Grant code, 509281
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
The feasibility of measuring bacterial load in exhaled breath of children with pneumonia/ empyema using a point-of-care test
Relevance of the study
Community acquired pneumonia (CAP) is one of the most common childhood infections in the UK and 40% of preschool children consult primary care for acute respiratory infections. Almost 75% of patients with acute respiratory tract infections receive antibiotics despite the fact that most infections are viral in origin. Identifying patients likely to benefit from antibiotic treatment and conversely those who can safely be managed without antibiotic treatment is an urgent priority. At the moment, there is no gold standard for diagnosis of pneumonia. Clinicians rely on physical signs, chest x-ray and laboratory tests. These diagnostic measures have varied degree of accuracy and they are expensive and or invasive.
The aim of this study is to obtain pilot data on the feasibility of measuring bacterial load in exhaled breath from children admitted to hospital with pneumonia and empyema and children without lower respiratory tract infection, as negative controls.
Inclusion criteria
Quantitative phase: Children 5-18 years with a diagnosis of pneumonia/empyema and volunteers within the same age group who do not have a chest infection.
Qualitative phase: Children and parents and or carers of children with CAP and health care professionals involved in care of children with chest infection.
Study site and participants
Children as inpatients in the emergency department inpatients and out patients in the Noah’s Ark Children’s Hospital for Wales. Health care professionals in these departments.
Study duration
The study will be conducted over 2 years. Patients recruited for the quantitative component will be in the study for 3 days and up to the end of the interviews for the qualitative part.
Participation entails
Breath sample collection at baseline and again at 24, 48 and 72 hours for children with pneumonia/empyema. Semi-structured interviews.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0006
Date of REC Opinion
12 Jun 2017
REC opinion
Further Information Favourable Opinion