Microdosing of BAC ONE to the Distal Lung (BAC ONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02558062|
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : March 26, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Respiratory Infections||Other: BAC ONE administration||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Clinical Study of Intrapulmonary Microdosing of the BACterial Detection Probe (BAC ONE) in Ventilator Associated Pneumonia|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: BAC ONE administration
All participants in this clinical study will be dosed on one occasion with BAC ONE. The final dosage will be 80 µg (± 25%).
Other: BAC ONE administration
BAC ONE will be administered to each patient during a bronchoscopy procedure. Fibre-based endomicroscopy and Cellvizio viewer software will be used to detect BAC ONE signal in the distal lung.
Other Name: BAC ONE
- The measurement of BAC ONE fluorescence intensity in the distal lung [ Time Frame: Fluorescence signal can be detected within a couple of minutes following BAC ONE administration. On average, signal analysis will be completed within one week of the procedure. ]The main primary outcome measure is to visualise the delivery of BAC ONE in the distal lung of both ventilated controls and patients with acute or chronic bacterial lung infection through the measurement of fluorescence using FE and Cellvizio viewer software.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558062
|Royal Infirmary Edinburgh|
|Edinburgh, United Kingdom, EH16 4TJ|
|Study Director:||Kev Dhaliwal, MBChB||University of Edinburgh|