Respiratory InfectionsEarly Phase 1BAC TWONCT02491164
Exploratory Study of Intrapulmonary Microdosing of Gram-negative Optical Imaging Detection Probe
A Early Phase 1 study testing BAC TWO and FE and Cellvizio viewer software in people with Respiratory Infections, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Infections
- What is being tested?
- BAC TWO and FE and Cellvizio viewer software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- Presence or scheduled presence of endo-tracheal tube.
- 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 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.
Who cannot join
- All cohorts
- Refusal for participation by attending consultant
- Any history of anaphylaxis or allergy to polymyxin-based antibiotics e.g. colomycin
- 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
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- Receiving drugs that cause increased autofluorescence in the lung, specifically amiodorane and methotrexate
- Cohort 4 only
- Inspired Oxygen Concentration (FiO2) >70%
- Positive End Expiratory Pressure (PEEP) >10cm
- Endotracheal tube (ETT) or tracheostomy internal diameter < 7mm
- Presence of pneumothorax
- Active bronchospasm
- Mean arterial pressure <65mmHg (millimeter of mercury) AND on vasopressor
- Platelet count < 50 x 109/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Clinical Study of Intrapulmonary Microdosing of Gram-negative Optical Molecular Imaging BACterial Detection Probe
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 TWO. BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can label gram-negative bacteria in the human lung.
Read the detailed description
The primary objective of this study is to deliver a BAC TWO microdose to 3 ventilated controls and 9 patients to assess the imaging parameters of BAC TWO over human autofluorescence and to assess if gram-negative 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 TWO 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 TWO 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 TWO probe. Routine blood investigations will be performed 4-6 hours following the administration of BAC TWO. The completion of all assessments at 4-6 hours post dose marks the end of the participant's participation in this study unless there are ongoing adverse events requiring resolution. The primary aim will be measured during bronchoscopy and all routine investigations will have been completed 6 hours post dose.
- Conditions
- Respiratory Infections
- Being tested
- BAC TWO, FE and Cellvizio viewer software
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAC TWOOther
BAC TWO administration
FE and Cellvizio viewer softwareDevice
Fibre based endomicroscopy to visualise fluorescent signal emitted by optical agents.
| Study group | Role | What they receive |
|---|---|---|
| BAC TWO administration | Experimental | All participants in this clinical study will be dosed on one occasion with BAC TWO. The final dosage will be 80 µg (± 25%). Receives: Other: BAC TWO; Device: FE and Cellvizio viewer software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging parameters of BAC TWO in the distal lung
The main primary outcome measure is to visualise the delivery of BAC TWO in the distal lung of both ventilated controls and patients with gram-negative bronchiectasis, gram-positive bronchiectasis and pulmonary infiltrates through the measurement of fluorescence using FE and Cellvizio viewer software.
Measured: up to 1 week post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Kev Dhaliwal, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491164
- Sponsor's protocol ID
- BAC TWO
- Acronym
- BAC TWO
- Status last verified
- Mar 2020
- First submitted
- 1 Jul 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Intrapulmonary Microdosing of Gram-negative Optical Molecular Imaging BACterial Detection Probe
- ClinicalTrials.gov ID
- NCT02491164
- Acronym / sponsor ID
- BAC TWO / BAC TWO
- Conditions
- Respiratory Infections
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 TWO. BAC TWO will be instilled directly into the lungs of 12 patients to assess whether it can label gram-negative bacteria in the human lung.
Detailed description
The primary objective of this study is to deliver a BAC TWO microdose to 3 ventilated controls and 9 patients to assess the imaging parameters of BAC TWO over human autofluorescence and to assess if gram-negative 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 TWO 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 TWO 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 TWO probe. Routine blood investigations will be performed 4-6 hours following the administration of BAC TWO. The completion of all assessments at 4-6 hours post dose marks the end of the participant's participation in this study unless there are ongoing adverse events requiring resolution. The primary aim will be measured during bronchoscopy and all routine investigations will have been completed 6 hours post dose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAC TWO administration | Experimental | Other: BAC TWO, Device: FE and Cellvizio viewer softwareAll participants in this clinical study will be dosed on one occasion with BAC TWO. The final dosage will be 80 µg (± 25%). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- All cohorts
- ≥ 16 years
- Attending consultant permission for bronchoscopy
- Cohort 1
- Patients scheduled to undergo surgery under general anaesthesia
Key exclusion criteria (15 listed)
- All cohorts
- Refusal for participation by attending consultant
- Any history of anaphylaxis or allergy to polymyxin-based antibiotics e.g. colomycin
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAC TWOBAC TWO administration | Other | BAC TWO administration |
| FE and Cellvizio viewer softwareFibre based endomicroscopy to visualise fluorescent signal emitted by optical agents. | Device | BAC TWO administration |
Primary outcome
Imaging parameters of BAC TWO in the distal lung
Time frame: up to 1 week post dose
The main primary outcome measure is to visualise the delivery of BAC TWO in the distal lung of both ventilated controls and patients with gram-negative bronchiectasis, gram-positive bronchiectasis and pulmonary infiltrates through the measurement of fluorescence using FE and Cellvizio viewer software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kev Dhaliwal, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BAC TWO and FE and Cellvizio viewer software in people with Respiratory Infections, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging parameters of BAC TWO in the distal lung (time frame: up to 1 week post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.