BAC ONE
Research type
Research Study
Full title
Exploratory clinical study of intrapulmonary microdosing of the BACterial detection probe (BAC ONE)
IRAS ID
191263
Contact name
Kev Dhaliwal
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Critically ill patients are often ventilated in dedicated critical care units to provide respiratory support. Despite best practice patients can often develop a condition called acute respiratory distress syndrome (ARDS), which is characterised by a deterioration in their lung function. The correct management for ARDS is identifying the underlying condition causing the deterioration and identifying appropriate targeted therapy. One such cause is pneumonia, caused by a bacterial infection in the lungs of a ventilated patient. The patients may have been ventilated due to pneumonia but they may also develop pneumonia whilst ventilated. Ventilator associated pneumonia (VAP) has significant mortality. Despite all the clinical and laboratory data there remains great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often based on experience rather than a complete understanding of the cause.
In an effort to address this problem, the research team have designed and synthesised an imaging agent that can detect bacteria in the distal lung. This study aims to test whether this probe (BAC ONE) labels bacteria in the human lung at very low concentrations in 3 ventilated patients who have no known lung infection (a comparison group), 6 non-ventilated patients with known chronic lung infection and in 3 patients in the intensive care unit (ICU). BAC ONE will be administered directly into the lungs during a bronchoscopy procedure and images of the lungs will be analysed. All patients will be monitored by the clinical research team for approximately 4-6 hours following dosing and blood and urine samples will be taken during this time. All participants will be contacted 24 hours following the procedure to make sure that no problems were encountered - this will mark the end of the participant's involvement.
REC name
Scotland A REC
REC reference
15/SS/0217
Date of REC Opinion
15 Jan 2016
REC opinion
Further Information Favourable Opinion