Condition category
Respiratory
Date applied
20/12/2019
Date assigned
06/01/2020
Last edited
03/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Community-acquired pneumonia (CAP) is an infection of the lungs where the lungs become inflamed. Severe CAP requires admission to hospital in specialised areas with increased nursing care such as intensive care (ICU) and may require the temporary support of a breathing machine (mechanical ventilation). In England pneumonia is the most common infection-related cause for ICU admission and UK data indicates that up to a third of patients admitted to an ICU with pneumonia die. Additionally, there is a large economic cost and survivors are often left with significant reductions in their quality of life.
Immune responses in the lung need to balance identification and clearance of disease-causing microbes with the collateral damage of lung inflammation and injury. Of particular interest are local immune cells that play a crucial role in protecting the lung against bacteria and viruses. These specialised immune cells remain in the lung and cannot be detected in the circulating blood of patients, so samples of lung cells must be taken.
This study will investigate local immune cells in mechanically ventilated patients with severe CAP. Studying the local immune response to severe CAP offers insights into how this disease occurs, may help decide which patients are going to need to most support and may identify new treatment targets for this important condition.

Who can participate?
People admitted to intensive care at Oxford University Hospitals Foundation NHS Trust who require mechanical ventilation

What does the study involve?
Doctors use samples taken from lung fluid to detect infection. This study will use the excess samples to measure the levels of immune cells in the lung fluid. The lung fluid is collected using a process called bronchoalveolar lavage. This involves passing a tube from the patient's mouth or nose into the lung, squirting in some saline (salt solution) and then sucking it back up the tube so that any cells or substances in the lung fluid can be examined.

What are the possible benefits and risks of participating?
There are no specific benefits to participating in this study and taking part in this study will not affect participants' care in any way. The lung fluid samples would be taken anyway as part of routine medical care.

Where is the study run from?
The Kadoorie Centre for Critical Care Research (UK)

When is the study starting and how long is it expected to run for?
February 2019 to January 2021

Who is funding the study?
Oxford University (UK)

Who is the main contact?
Christopher Andersen, christopher.andersen@ndcn.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Andersen

ORCID ID

http://orcid.org/0000-0002-9321-8660

Contact details

Kadoorie Centre for Critical Care Research
Level 3 John Radcliffe Hospital
Oxford University Hospitals Foundation NHS Trust
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 223101
chris_andersen@gmp.usyd.edu.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PID 14303, IRAS 263517

Study information

Scientific title

ImmuneCAP: T-cell responses in severe community acquired pneumonia, a pilot observational study

Acronym

ImmuneCAP

Study hypothesis

Community acquired pneumonia (CAP) is a pathogen-driven inflammatory process of the lung parenchyma characterised by an exudative infiltration of alveolae causing impairment of lung function. Our understanding of the underlying processes associated with this condition is incomplete. In this study we will study the local immune responses in pneumonia through analysis of bronchioalveolar lavage fluid.

Ethics approval

Approved 30/10/2019, Yorkshire & The Humber – Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 1048 088), ref: 19/YH/0289

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Community-acquired pneumonia

Intervention

This observational study will compare consented patients with severe acute pneumonia to consented patients with and without lung injury. Once enrolled in the study, the participant will have a bronchoalveolar lavage sample taken and will be followed up for 90 days or until hospital discharge.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Quantity and phenotype of lung-derived T-cell populations measured using flow cytometry at a single timepoint within 72 h of the establishment of mechanical ventilation

Secondary outcome measures

Severity of respiratory failure and other organ failure using the sequential organ failure assessment (SOFA) score during the 90 days following admittance or the period from hospital admittance to discharge

Overall trial start date

01/02/2019

Overall trial end date

20/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Admitted to a critical care setting in the Oxford University Hospital Trust
2. Mechanically ventilated for less than 72 h
3. Diagnosis of community acquired pneumonia has been made by the treating physicians based on the following criteria:
3.1. Symptoms and/or signs consistent with a lower respiratory tract infection
3.2. Radiological evidence of new onset consolidation on a chest x-ray or CT scan
4. Aged ≥16 years
5. Able to consent themselves or declaration obtained from a personal or professional consultee

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Previously included in the study
2. Hospital admission in the past 30 days (prior to this current presentation)
3. Long-term resident of a nursing home or other residential care facility

Recruitment start date

21/12/2019

Recruitment end date

20/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals Foundation NHS Trust
Kadoorie Centre, Level 3 John Radcliffe Hospital Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials Research Group
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
+44 01865 616480
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

University/education

Funder name

Medical Sciences Division, University of Oxford

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study will be published in a peer-reviewed journal and presented at local, national and international meetings. Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. The results of the study will be summarised on the Critical Care Research Group webpages: https://www.ndcn.ox.ac.uk/research/critical-care-research-group-kadooriecentre .

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/06/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/01/2020: Trial's existence confirmed by Yorkshire & The Humber – Leeds East Research Ethics Committee.