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Microdosing of BAC ONE to the Distal Lung | Recruiting
Microdosing of BAC ONE to the Dista... | Recruiting
Microdosing of BAC ONE to the Distal Lung
BAC ONE

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Medical Conditions
  • Bacterial Respiratory Infections
Primary Contact Details
Annya M Smyth, PhD
0131 242 9180
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02558062
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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)

    - 3 bronchiectasis patients with predominant colonisation with gram-negative bacteria (cohort 2)

    - 3 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.
Phase
Early Phase 1
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Other : BAC ONE administration

Study Arm Groups : BAC ONE administration

Intervention Type
See Interventions above
Primary Outcome Measures
    The measurement of BAC ONE fluorescence intensity in the distal lung; 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.
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
16 Years - N/A
Who Can Participate
Patients
Number of Participants
12
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Edinburgh
EH16 4TJ
Trial Contact(s)
Primary Trial Contact
Annya M Smyth, PhD
0131 242 9180
Other Trial Contacts
Kev Dhaliwal, MBChB
0131 242 9180
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Exploratory Clinical Study of Intrapulmonary Microdosing of the BACterial Detection Probe (BAC ONE) in Ventilator Associated Pneumonia
EudraCT Number
Not available for this trial
Funder(s)
  • NHS Lothian
Other Study ID Numbers
BAC ONE
Sponsor(s)
University of Edinburgh
Key Dates

Recruitment Start Date

May 2016

Recruitment End Date

Dec 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

17 Sep 2015

Date updated in source

19 Feb 2018