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Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit

NCT02804854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-11-04

No results posted yet for this study

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. 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

Interventions

DRUG

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%).

Sponsors & Collaborators

Principal Investigators

  • Kev Dhaliwal, MRCP PhD · University of Edinburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804854 on ClinicalTrials.gov