BAC TWO
Research type
Research Study
Full title
Exploratory clinical study of intrapulmonary microdosing of gram-negative optical molecular imaging BACterial detection probe (BAC TWO)
IRAS ID
185718
Contact name
Kev Dhaliwal
Contact email
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 adult 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 which is caused by a bacterial infection in the lungs. 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 a subset of bacterial cells (gram-negative bacteria). This study aims to test whether this probe (BAC TWO) labels gram-negative 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 ventilated patients in the intensive care unit (ICU). BAC TWO 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.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0126
Date of REC Opinion
23 Sep 2015
REC opinion
Further Information Favourable Opinion