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Microdosing of BAC ONE to the Distal Lung (BAC ONE)

Primary Purpose

Bacterial Respiratory Infections

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BAC ONE administration
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bacterial Respiratory Infections focused on measuring Ventilator Associated Pneumonia, Distal lung

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All cohorts

  • ≥ 16 years
  • Attending consultant permission for bronchoscopy

Cohort 1

  • Patients scheduled to undergo surgery under general anaesthesia
  • Absence of acute or significant chronic lung disease as determined by the clinical suspicion of the attending medical team or of a medically qualified member of the study investigation team.
  • Scheduled presence of an endo-tracheal tube (ETT).
  • Capacity to provide informed consent

Cohort 2 and 3

  • Patients with bronchiectasis with known microbiological predominance of gram-negative or gram-positive bacteria.
  • Capacity to provide informed consent

Cohort 4

  • Patients in the ICU with suspected VAP and pulmonary infiltrates on radiological assessment
  • Presence of invasive tracheal ventilation tube
  • Provision of informed consent from the patient or their personal legal representative prior to any study related procedures.

Exclusion Criteria:

All cohorts

  • Refusal for participation by attending consultant
  • Any history of anaphylaxis
  • Significant coagulopathy, which causes bronchoscopy to be unsuitable, as determined by clinical co-investigator or the participant's attending consultant, using information which is routinely available
  • Myocardial infarction in the preceding four weeks
  • Women who are pregnant or are breastfeeding
  • Receiving drugs that cause increased autofluorescence in the lung, specifically amiodorane and methotrexate

Participants in cohort 4 only

  • Inspired Oxygen Concentration (FiO2) >70%
  • Positive End Expiratory Pressure (PEEP) >10cm
  • ETT or tracheostomy internal diameter < 7mm
  • Presence of pneumothorax
  • Active bronchospasm
  • Mean arterial pressure <65mmHg AND on vasopressor
  • Platelet count < 50 x 109/L

Sites / Locations

  • Royal Infirmary Edinburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BAC ONE administration

Arm Description

All participants in this clinical study will be dosed on one occasion with BAC ONE. The final dosage will be 80 µg (± 25%).

Outcomes

Primary Outcome Measures

The measurement of BAC ONE fluorescence intensity in the distal lung
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2015
Last Updated
March 24, 2020
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT02558062
Brief Title
Microdosing of BAC ONE to the Distal Lung
Acronym
BAC ONE
Official Title
Exploratory Clinical Study of Intrapulmonary Microdosing of the BACterial Detection Probe (BAC ONE) in Ventilator Associated Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Respiratory Infections
Keywords
Ventilator Associated Pneumonia, Distal lung

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAC ONE administration
Arm Type
Experimental
Arm Description
All participants in this clinical study will be dosed on one occasion with BAC ONE. The final dosage will be 80 µg (± 25%).
Intervention Type
Other
Intervention Name(s)
BAC ONE administration
Other Intervention Name(s)
BAC ONE
Intervention Description
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.
Primary Outcome Measure Information:
Title
The measurement of BAC ONE fluorescence intensity in the distal lung
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All cohorts ≥ 16 years Attending consultant permission for bronchoscopy Cohort 1 Patients scheduled to undergo surgery under general anaesthesia Absence of acute or significant chronic lung disease as determined by the clinical suspicion of the attending medical team or of a medically qualified member of the study investigation team. Scheduled presence of an endo-tracheal tube (ETT). Capacity to provide informed consent Cohort 2 and 3 Patients with bronchiectasis with known microbiological predominance of gram-negative or gram-positive bacteria. Capacity to provide informed consent Cohort 4 Patients in the ICU with suspected VAP and pulmonary infiltrates on radiological assessment Presence of invasive tracheal ventilation tube Provision of informed consent from the patient or their personal legal representative prior to any study related procedures. Exclusion Criteria: All cohorts Refusal for participation by attending consultant Any history of anaphylaxis Significant coagulopathy, which causes bronchoscopy to be unsuitable, as determined by clinical co-investigator or the participant's attending consultant, using information which is routinely available Myocardial infarction in the preceding four weeks Women who are pregnant or are breastfeeding Receiving drugs that cause increased autofluorescence in the lung, specifically amiodorane and methotrexate Participants in cohort 4 only Inspired Oxygen Concentration (FiO2) >70% Positive End Expiratory Pressure (PEEP) >10cm ETT or tracheostomy internal diameter < 7mm Presence of pneumothorax Active bronchospasm Mean arterial pressure <65mmHg AND on vasopressor Platelet count < 50 x 109/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kev Dhaliwal, MBChB
Organizational Affiliation
University of Edinburgh
Official's Role
Study Director
Facility Information:
Facility Name
Royal Infirmary Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Microdosing of BAC ONE to the Distal Lung

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