Bacterial Respiratory Infections Clinical Trial
Official title:
Exploratory Clinical Study of Intrapulmonary Microdosing of the BACterial Detection Probe (BAC ONE) in Ventilator Associated Pneumonia
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 deterioration in their
respiratory function, and changes on chest x-ray. 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 at the investigators' disposal there remains
great difficulty in the accurate diagnosis of pneumonia and therefore treatment is often
given empirically. Therefore, there is an urgent clinical need for accurate methods to
diagnose the presence of bacteria deep in the lung in ventilated critically ill patients. As
such, the investigating team have developed and synthesised an imaging agent called BAC ONE.
BAC ONE will be instilled directly into the lungs of 12 patients (with and without lung
infection) to assess whether it can label bacteria in the human lung.
The primary objective of this study is to deliver a BAC ONE microdose to ventilated controls
and patients with lung infection to assess the imaging parameters of BAC ONE over human
autofluorescence and to assess if bacteria can be detected in vivo in situ within the distal
lung.
The primary endpoint is to visualise the delivery of a microdose of BAC ONE and assess
imaging parameters in:
- 3 mechanically ventilated patients to provide a control population (cohort 1)
- 6 bronchiectasis patients with predominant colonisation with gram-negative bacteria
(cohort 2)
- 6 bronchiectasis patients with predominant colonisation with gram-positive bacteria
(cohort 3)
- 3 patients with suspected pneumonia and pulmonary infiltrates in ICU (cohort 4)
For all cohorts, eligibility will be verified by a clinical trial physician after written
informed consent has been obtained. For all cohorts, a bronchoscopy with lavage will be
performed to harvest broncho-alveolar lavage fluid (BALF). Fibre-based endomicroscopy (FE)
will be performed on up to three areas and up to 80μg (± 25%) in total of BAC ONE will be
instilled in up to 3 sites.
Participants will be asked to provide additional blood and urine samples with the intention
of examining for systemic uptake of the BAC ONE probe. Routine blood investigations will be
performed 4-6 hours following the administration of BAC ONE. All participants will either be
contacted by a member of the research team via telephone or ward visit 24 hours (± 4 hours)
after BAC ONE dosing to ensure no AEs/SAEs were experienced. The participant's involvement in
the study is concluded when the 24 hour assessment has been successfully completed and all
AEs/SAEs have been resolved.
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