ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001721897

Ethics application status

Approved

Date submitted

14/07/2021

Date registered

16/12/2021

Date last updated

17/11/2022

Date data sharing statement initially provided

16/12/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

ImmuneCAP: Immune responses in severe community acquired pneumonia

Scientific title

ImmuneCAP: Tissue-resident memory T cell response in severe community acquired pneumonia

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ImmuneCAP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Community Acquired Pneumonia

Sepsis

COVID-19

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

We will analyse tissue samples (blood and bronchial washings) of patients with severe community acquired pneumonia (CAP) and compare these with patients without CAP. Samples will be collected during the intensive care admission by an appropriately trained intensive care doctor or nurse within 72 hours of intubation. Bronchial washings will be collected via a formal bronchoscope if clinically indicated or by passing a catheter through an endotracheal tube and introducing and aspirating a small amount of sterile saline solution (10-20ml). Blood samples will be collected via a central line, arterial line or via venesection when clinically indicated. Outcomes will be assessed at discharge from hospital via the electronic patient record with no further participant involvement post discharge.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Control groups will be participants with non infective causes of lung inflammation and participants without infection or lung inflammation

Control group

Active

Outcomes

Primary outcome [1]

Survival as determined by review of the electronic patient record

Timepoint [1]

Hospital discharge

Primary outcome [2]

Tissue resident memory response as determined by flow cytometry

Timepoint [2]

At time of sample collection within 72 hour of intubation

Secondary outcome [1]

Days free of mechanical ventilation as determined by review of the electronic patient record

Timepoint [1]

28 days post initial intubation

Secondary outcome [2]

Acute Physiology and Chronic Health Evaluation (APACHE) Score assessed via the electronic patient record

Timepoint [2]

24 hours after admission to Intensive Care

Secondary outcome [3]

PaO2 in mmHg/FiO2 as fraction of 1.0 (lowest) as determined by review of the electronic patient record

Timepoint [3]

in first 72 hours of admission

Secondary outcome [4]

Sequential Organ Failure Assessment Score as assessed by review of the electronic patient record

Timepoint [4]

At time of sample acquisition within 72 hours of intubation

Secondary outcome [5]

Bronchial washing mRNA analysis

Timepoint [5]

At time of sample acquisition within 72 hours of intubation

Secondary outcome [6]

Peripheral blood mRNA analysis

Timepoint [6]

At time of sample acquisition within 72 hours of intubation

Eligibility

Key inclusion criteria

Admitted to a critical care setting
• A diagnosis of community acquired pneumonia has been made by the treating physicians
based on the following criteria;
- Symptoms and/or signs consistent with a lower respiratory tract infection
- Radiological evidence of new onset consolidation on a chest x-ray or CT scan
• Mechanically ventilated for less than 72 hours
• Age equal to or greater than 18 years old
• Participant consent or person responsible consent
• Patients with confirmed COVID-19 disease meeting the criteria for CAP will be included in
the study

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previously included in the study

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Case control

Timing

Prospective

Statistical methods / analysis

Associations between wet-lab data and clinical parameters will be determined by Spearman’s Correlation. RNA will be analysed using the Nanostring nCounter
Sprint machine and RNA panels analysed using the nSolver (Nanostring, Seattle, USA) and g:profiler software (https://biit.cs.ut.ee/gprofiler/) to generate volcano plots and Pathway Analysis “Manhattan plots”, respectively. Single-cell protein-RNA analysis will be analysed on the BD machine and using the in-built pipeline

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/08/2021

Date of last participant enrolment

Anticipated

1/08/2026

Actual

Date of last data collection

Anticipated

1/11/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [3]

Prince of Wales Private Hospital - Randwick

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2010 - Darlinghurst

Recruitment postcode(s) [3]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Intensive Care Foundation Australia and New Zealand

Address [1]

Suite 1.01, Level 1, 277 Camberwell Road Camberwell, VIC 3124

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of New South Wales

Address [2]

Level 6, Wallace Wurth Building High Street, UNSW Australia Kensington NSW 2052

Country [2]

Australia

Primary sponsor type

Other

Name

The George Institute for Global Health

Address

Level 5, 1 King Street
Newtown 2042
NSW, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District

Ethics committee address [1]

NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/08/2020

Approval date [1]

17/09/2020

Ethics approval number [1]

2020/ETH00047

Summary

Brief summary

Community acquired pneumonia (CAP) is an infection of the lungs where the lungs become inflamed. CAP is most commonly caused by bacterial infections however during the seasonal ‘flu epidemics and novel pandemics such as COVID-19, viral infections may predominate. Severe CAP requires treatment in an intensive care unit (ICU) and often support of breathing with a ventilator. In Australia pneumonia is the most common infection treated in ICU and unfortunately often proves fatal. Additionally, there is a large economic cost and survivors are often left with significant reductions in their quality of life. 

The body’s immune responses in the lung is designed to kill and eliminate the bacteria or viruses causing the infection but can also cause collateral damage to the lung through inflammation and injury. the lung has specialised immune cells called Tissue Resident Memory T-cells, (TRM)that play a crucial role in protecting the lung against bacteria and viruses. As the name suggests this specialised type of immune cells are ‘resident’ in the lung tissues and are not detected in the circulating blood. In this preliminary study we will evaluate a system to collect and study TRM -cells in mechanically ventilated patients with severe CAP. We will compare the immune responses of patients with severe CAP caused by COVID-19, other viral infections and bacterial infections. We will also compare patients with severe CAP to two different control groups. The first control group will be mechanically ventilated patients with lung injury not caused by infection. The second control group will be mechanically ventilated patients without evidence of lung injury. 

Studying the local immune response in this way will offer insights into how severe CAP occurs, may help identify which patients are going to need to most support and may identify new treatments for this important condition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Christopher Andersen

Address

Intensive Care Department Royal North Shore Hospital Reserve Road St Leonards NSW 2065

Country

Australia

Phone

+61294632580

Fax

[email protected]

Contact person for public queries

Name

Christopher Andersen

Address

Intensive Care Department Royal North Shore Hospital Reserve Road St Leonards NSW 2065

Country

Australia

Phone

+61294632580

Fax

[email protected]

Contact person for scientific queries

Name

Christopher Andersen

Address

Intensive Care Department Royal North Shore Hospital Reserve Road St Leonards NSW 2065

Country

Australia

Phone

+61294632580

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Non commercial researchers with appropriate Human Research Ethics Committee approval

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified data may be shared following approval from the study management team

What types of analyses could be done with individual participant data?

• Database analyses

When can requests for individual participant data be made (start and end dates)?

From:
At the conclusion of the recruitment and follow up period, anticipated to be 01/08/2024, the data will be retained for a minimum of 5 years as per institutional requirements

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• By contacting the study coordinator via The George Institute for Global Health
[email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically