Lung DiseasePhase 2SNAP-ITNCT02804854
Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit
A Phase 2 study testing Neutrophil Activation Probe (NAP) in people with Lung Disease, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
Critically ill patients often succumb to acute respiratory disease (rapidly developing disease affecting the lungs). The lungs are the commonest organ to fail and require support in the intensive care environment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- Neutrophil Activation Probe (NAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2016to Jul 2022
- Phase
- Phase 2
- 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
- For all participants:
- Participants aged 16 years or over
- Participants who are predicted to require intubation for more than two calendar days, with this assessment made by a clinician (Registrar or Consultant in Intensive Care) who is independent of the study team.
- Participants who have undergone chest radiological imaging within the preceding 48 hours prior to enrolment.
- Participants who can undergo study bronchoscopy within the initial time period (C.D. 0-2) of first intubation in their present hospital admission (as determined by the absence of exclusion criteria for bronchoscopy laid out below).
- For BAL subset (up to a total of 10 participants)
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- Permission given to undertake a BAL by independent attending consultant
- CONTROL BAL (n=5)
- o Absence of pulmonary infiltrates on the aforementioned chest radiological imaging
- ABNORMAL BAL (n=5)
- Pulmonary infiltrate on chest radiological imaging
- Suspicion of community acquired pneumonia or ventilator associated pneumonia as determined by the clinical care team.
Who cannot join
- For enrolment into the study:
- Absence of consent from the participant or their personal or professional legal representative
- Documented history of allergy to fluorescein
- Pregnancy Prior to each bronchoscopy (as assessed within 24 hours of the start of the procedure)
- Investigator not available to perform bronchoscopy with NAP/FE within the pre-specified time
- Treatment withdrawal documented to take place within the next 24 hours
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- Presence of pneumothorax or intercostal chest drain
- Refusal by the patient's attending intensive care consultant
- Prior to each study blood sampling • Haemoglobin (Hb) < 6.5 g/dL.
- Prior to each BAL
- Refusal to permit BAL by the participants attending consultant
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Ward 118 Intensive Care, Royal Infirmary of Edinburgh
Edinburgh, Edinburgh City, EH16 4TJ
Western General Hospital
Edinburgh, Edinburgh City, EH4 2XU
About this study
Critically ill patients often succumb to acute respiratory disease (rapidly developing disease affecting the lungs). The lungs are the commonest organ to fail and require support in the intensive care environment. However, no accurate methods exist that can be used at the bedside to tell what is causing deterioration in a person's lungs. There are various examples of acute respiratory diseases that can occur as a result of numerous different causes, have a high risk of death and cannot be treated easily with drugs. When trying to accurately diagnose and classify these lung diseases there is a risk that the type of respiratory disease is misdiagnosed, missed or the level of severity is not captured. By using the field of optical molecular imaging and employing novel techniques and technologies, the investigators hope to demonstrate here that a bespoke chemical probe administered in micro doses (tiny doses) directly into the distal lung can rapidly and accurately detect activated neutrophils (cells of the immune system that are implicated in the development of these severe conditions), and so work towards a bedside test which could be used to diagnose, monitor and classify the disease in patients who are critically ill in the future. The population for this study are in intensive care where patients are normally intubated (have a breathing tube) due to the severity of their illness, this may be because of respiratory problems or respiratory problems can rapidly develop. Participants will have the chemical probe administered into their lungs and pictures taken through the tube already in place. As this probe lights up when it comes into contact with neutrophils the investigators will be able to tell if neutrophils are present. This will inform a larger study in which it's hoped that the method can be used to inform clinical decisions. The first procedure will take place within two days of initiation of mechanical ventilation and the direct contact with the study team will be completed within nine days.
- Conditions
- Lung Disease
- Being tested
- Neutrophil Activation Probe (NAP)
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil Activation Probe (NAP)Drug
Delivery of NAP by direct pulmonary administration followed by fibreoptic confocal microendoscopy. A total of 240 mcg (±25%) in three divided doses of 80 mcg (±25%).
| Study group | Role | What they receive |
|---|---|---|
| Patients in ICU | Experimental | Delivery of Neutrophil Activation Probe (NAP) (80mcgs) to ventilated patients up to three times. Receives: Drug: Neutrophil Activation Probe (NAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of NAP signal
The reliability of the NAP/FE procedure as determined by the reproducibility of NAP signal during multiple transbronchial passes of the same segment in the same patient, averaged over the entire enrolled population.
Measured: Length of the study - two years
Discriminant ability of NAP signal in normal or abnormal lung segments
The accuracy of the NAP/FE procedure as determined by the discriminant ability of NAP signal in normal or abnormal lung segments, where the reference standard is contemporaneous clinician interpretation of available radiology at the time of study procedure.
Measured: Length of the study - two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Kev Dhaliwal, MRCP PhD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804854
- Sponsor's protocol ID
- AC16025
- Acronym
- SNAP-IT
- Status last verified
- Dec 2016
- First submitted
- 2 Jun 2016
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit
- ClinicalTrials.gov ID
- NCT02804854
- Acronym / sponsor ID
- SNAP-IT / AC16025
- Conditions
- Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Dec 2016
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 17 Jun 2016 (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 often succumb to acute respiratory disease (rapidly developing disease affecting the lungs). The lungs are the commonest organ to fail and require support in the intensive care environment. However, no accurate methods exist that can be used at the bedside to tell what is causing deterioration in a person's lungs. There are various examples of acute respiratory diseases that can occur as a result of numerous different causes, have a high risk of death and cannot be treated easily with drugs. When trying to accurately diagnose and classify these lung diseases there is a risk that the type of respiratory disease is misdiagnosed, missed or the level of severity is not captured. By using the field of optical molecular imaging and employing novel techniques and technologies, the investigators hope to demonstrate here that a bespoke chemical probe administered in micro doses (tiny doses) directly into the distal lung can rapidly and accurately detect activated neutrophils (cells of the immune system that are implicated in the development of these severe conditions), and so work towards a bedside test which could be used to diagnose, monitor and classify the disease in patients who are critically ill in the future. The population for this study are in intensive care where patients are normally intubated (have a breathing tube) due to the severity of their illness, this may be because of respiratory problems or respiratory problems can rapidly develop. Participants will have the chemical probe administered into their lungs and pictures taken through the tube already in place. As this probe lights up when it comes into contact with neutrophils the investigators will be able to tell if neutrophils are present. This will inform a larger study in which it's hoped that the method can be used to inform clinical decisions. The first procedure will take place within two days of initiation of mechanical ventilation and the direct contact with the study team will be completed within nine days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in ICU | Experimental | Drug: Neutrophil Activation Probe (NAP)Delivery of Neutrophil Activation Probe (NAP) (80mcgs) to ventilated patients up to three times. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Participants aged 16 years or over
- Participants who are predicted to require intubation for more than two calendar days, with this assessment made by a clinician (Registrar or Consultant in Intensive Care) who is independent of the study team.
- Participants who have undergone chest radiological imaging within the preceding 48 hours prior to enrolment.
- Participants who can undergo study bronchoscopy within the initial time period (C.D. 0-2) of first intubation in their present hospital admission (as determined by the absence of exclusion criteria for bronchoscopy laid out below).
- For BAL subset (up to a total of 10 participants)
Key exclusion criteria (11 listed)
- Absence of consent from the participant or their personal or professional legal representative
- Documented history of allergy to fluorescein
- Pregnancy Prior to each bronchoscopy (as assessed within 24 hours of the start of the procedure)
- Investigator not available to perform bronchoscopy with NAP/FE within the pre-specified time
- Treatment withdrawal documented to take place within the next 24 hours
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 |
|---|---|---|
| Neutrophil Activation Probe (NAP)Delivery of NAP by direct pulmonary administration followed by fibreoptic confocal microendoscopy. A total of 240 mcg (±25%) in three divided doses of 80 mcg (±25%). | Drug | Patients in ICU |
Primary outcome
Reproducibility of NAP signal
Time frame: Length of the study - two years
The reliability of the NAP/FE procedure as determined by the reproducibility of NAP signal during multiple transbronchial passes of the same segment in the same patient, averaged over the entire enrolled population.
Discriminant ability of NAP signal in normal or abnormal lung segments
Time frame: Length of the study - two years
The accuracy of the NAP/FE procedure as determined by the discriminant ability of NAP signal in normal or abnormal lung segments, where the reference standard is contemporaneous clinician interpretation of available radiology at the time of study procedure.
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 4 Nov 2022.
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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, MRCP PhD study director
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neutrophil Activation Probe (NAP) in people with Lung Disease, run by University of Edinburgh at 2 sites 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 12 inclusion and 11 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reproducibility of NAP signal (time frame: Length of the study - two years). The study lists 2 primary outcomes in all. 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 4 Nov 2022.