Critically Ill, Mechanically VentilatedPhase 3TEAM(III)NCT03133377

Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

A Phase 3 study testing Early activity and mobilisation in people with Critically Ill, Mechanically Ventilated, run by Australian and New Zealand Intensive Care Research Centre at 49 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critically Ill, Mechanically Ventilated
What is being tested?: Early activity and mobilisation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 49 sitesin 5 countries
Study dates: 28 Feb 2018to 10 Nov 2022
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 years or older.
Intubated and expected to remain invasively mechanically ventilated the day after tomorrow.
Sufficient cardiovascular stability to make mobilisation potentially possible, as indicated by:
the absence of current brady-arrhythmia requiring pharmacological support
a current ventricular rate ≤ 150 bpm
most recent lactate ≤ 4.0 mmol/L

Show all 14Show fewer

current combined noradrenaline/adrenaline infusion rate of ≤ 0.2 mcg/kg/min, OR if noradrenaline/adrenaline infusion rate has increased by more than 25% in the last 6 hours, dose must be <0.1 mcg/kg/min.
most recent cardiac index ≥ 2.0 L/min/m2 (where measured)
no current requirement for VA ECMO
Sufficient respiratory stability to make mobilisation potentially possible, as indicated by:
current FiO2 ≤ 0.6
current PEEP ≤ 16 cm H20
an absence of current requirement for NO, prone ventilation, neuromuscular blockers, ventilation, prostacyclin, VV ECMO or HFOV
current RR ≤ 45 bpm

Who cannot join

Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable).
Documented cognitive impairment.
Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury).
Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness).
Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs.
Life expectancy less than 180 days due to a chronic or underlying medical condition.

Show all 10Show fewer

Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision maker are not committed to full active treatment.
Unable to communicate in the official local language.
This is not the first ICU admission in the index hospital admission.
Fulfilled all inclusion criteria and none of the exclusion criteria ≥ 72 hours

Trial locations and contacts

49 sites in 5 countries.

Country

City, postcode or hospital

49 sites in 5 countries

Australia28 sites

Royal Adelaide Hospital
Adelaide, South Australia
Sunshine Coast University Hospital
Birtinya, Queensland
Mater Health
Brisbane, Queensland
Mater Private Hospital
Brisbane, Queensland
Caboolture Hospital
Caboolture, Queensland
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Prince Charles Hospital
Chermside West, Queensland
Geelong Hospital - Barwon Health
Geelong, Victoria, 3220
Launceston General Hospital
Launceston, Tasmania
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Austin Health
Melbourne, Victoria
Cabrini Health
Melbourne, Victoria
Epworth Richmond
Melbourne, Victoria
Western Health
Melbourne, Victoria
Royal Melbourne Hospital
Melbourne
Sir Charles Gairdner Hospital
Nedlands, Western Australia
Fiona Stanley Hospital
Perth, Western Australia, 6150
Royal Perth Hospital
Perth, Western Australia
Alfred Hospital
Prahran, Victoria, 3004
Redcliffe Hospital
Redcliffe, Queensland
Rockhampton Hospital
Rockhampton, Queensland
St John of God Hospital
Subiaco, Western Australia
St George Hospital
Sydney, New South Wales, 2217
John Hunter Hospital
Sydney, New South Wales
Royal North Shore Hospital
Sydney, New South Wales
Toowoomba Hospital
Toowoomba, Queensland
Wollongong Hospital
Wollongong, New South Wales
Princess Alexandra Hospital
Woolloongabba, Queensland

Other trials in Australia

United Kingdom9 sites

Bristol Royal Infirmary
Bristol
Frimley Park Hospital
Frimley
University Hospital Lewisham
Lewisham
King's College Hospital
London
Nottingham University Hospitals
Nottingham
Royal Berkshire Hospital
Reading
Morriston Hospital
Swansea
Royal Cornwall Hospital
Truro
Queen Elizabeth Hospital Woolwich
Woolwich

Other trials in United Kingdom

New Zealand5 sites

Auckland City Hospital (CVICU)
Auckland
Auckland City Hospital (DCCM)
Auckland
Waikato Hospital
Hamilton
Tauranga Hospital
Tauranga
Wellington Hospital
Wellington

Other trials in New Zealand

Ireland4 sites

Beacon Hospital
Dublin
St Vincent's Hospital
Dublin
Galway Hospital
Galway
Tallaght Hospital
Tallaght

Other trials in Ireland

Germany3 sites

The Charité
Berlin
Universitätsklinikum Leipzig
Leipzig
Klinikum rechts der Isar der Technischen Universität Mϋnchen
Munich

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About this study

Official title: A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care

The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

Read the detailed description

The TEAM Trial is a definitive phase III multi-centre randomised controlled trial in mechanically ventilated patients. Supported by compelling preliminary data, the trial will determine whether early activity and mobilisation during mechanical ventilation improves days alive and at home at 6 months compared to standard care. Recruiting 750 patients, this will be the largest trial ever conducted of early mobilisation.

Patients allocated to the early activity and mobilisation protocol (intervention group) will be assessed by a physiotherapist daily during the ICU stay to determine the highest level of mobility. This will determine the dosage and type of exercise that will be delivered, led by the physiotherapist with assistance from the multidisciplinary team. For both groups, concomitant care will be guided by the treating clinician. In addition, all post-ICU patient management will be at the discretion of the patient's ward-based treating physicians.

Patients will be randomized via web-based system and de-identified data will be collected on the following: baseline demographics; comorbidities; sedatives, analgesics, corticosteroids and neuromuscular blockers; pain/sedation/delirium scores; tracheostomy, intubation and renal replacement therapy. The intervention will be administered during the ICU stay upto 28days and the Day 180 follow up will be conducted centrally.

Conditions: Critically Ill, Mechanically Ventilated
Being tested: Early activity and mobilisation
Keywords: Early activity and mobilization, rehabilitation, intensive care
Medical subject headings: Critical Illness, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early activity and mobilisationBehavioural
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Study groups in NCT03133377
Study group	Role	What they receive
Early activity and Mobilisation intervention	Experimental	Patients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after. Receives: Behavioral: Early activity and mobilisation
Standard of care	No intervention	The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of days alive and out of hospital
Any days spent in rehabilitation or a nursing home counted as days in hospital
Measured: between randomisation and 180 days

Secondary outcomes (7)

All-cause mortality
Measured: From date of randomisation up to180days.
Time from randomisation until death
Measured: From date of randomisation unitl date of death from all cause, censored at 180days
Ventilator-free days
patients who die prior to day 28 will be assigned zero ventilator-free days
Measured: From date of randomisation until day 28
ICU-free days
patients who die prior to day 28 will be assigned zero ICU-free days
Measured: From date of randomisation until day 28
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Measured: Assessed at 180days
Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL)
Measured: Assessed at 180days
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)
Measured: Assessed at 180days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201810 Nov 2022

First posted28 Apr 2017
Study start28 Feb 2018
Primary completion18 May 2022
Study completion10 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Critically Ill, Mechanically VentilatedStudies of the same condition, open and under way.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03133377
Sponsor's protocol ID: TEAM U1111-1195-3567
Acronym: TEAM(III)
Status last verified: Dec 2023
First submitted: 10 Apr 2017
Last updated: 18 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.
PubMed 26968024
Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
PubMed 27864615
Iwashyna TJ, Hodgson CL. Early mobilisation in ICU is far more than just exercise. Lancet. 2016 Oct 1;388(10052):1351-1352. doi: 10.1016/S0140-6736(16)31745-7. No abstract available.
PubMed 27707476
Higgins AM, Lee YY, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Hodgson CL; Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Study Investigators. The Cost-Effectiveness of Early Active Mobilization During Mechanical Ventilation in the ICU: An Economic Evaluation Alongside the Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Trial. Crit Care Med. 2025 Sep 1;53(9):e1725-e1735. doi: 10.1097/CCM.0000000000006715. Epub 2025 May 27.
PubMed 40439527
Broadley T, Serpa Neto A, Bailey M, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Higgins AM, Hodgson CL; TEAM Trial Investigators. Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial. Aust Crit Care. 2025 May;38(3):101156. doi: 10.1016/j.aucc.2024.101156. Epub 2025 Jan 17.
PubMed 39826257
Presneill JJ, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna T, Neto AS, Nichol A, Schaller SJ, Sivasuthan J, Tipping C, Webb S, Young P, Hodgson CL; TEAM Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Crit Care Resusc. 2023 Oct 18;23(3):262-272. doi: 10.51893/2021.3.OA3. eCollection 2021 Sep 6.
PubMed 38046085
TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.
PubMed 36286256

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care
ClinicalTrials.gov ID: NCT03133377
Acronym / sponsor ID: TEAM(III) / TEAM U1111-1195-3567
Conditions: Critically Ill, Mechanically Ventilated
Keywords: Early activity and mobilization, rehabilitation, intensive care
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
Collaborators: National Health and Medical Research Council, Australia, ANZICS Clinical Trials Group, Medical Research Institute of New Zealand, Intensive Care National Audit & Research Centre
Study start: 28 Feb 2018 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 10 Nov 2022 (actual)
First posted: 28 Apr 2017 (actual)
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.

The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early activity and Mobilisation intervention	Experimental	Behavioral: Early activity and mobilisationPatients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after.
Standard of care	No intervention	–The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Aged 18 years or older.
Intubated and expected to remain invasively mechanically ventilated the day after tomorrow.
Sufficient cardiovascular stability to make mobilisation potentially possible, as indicated by:
Sufficient respiratory stability to make mobilisation potentially possible, as indicated by:

Key exclusion criteria (10 listed)

Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable).
Documented cognitive impairment.
Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury).
Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness).
Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs.

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
Early activity and mobilisationThe early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities	Behavioural	Early activity and Mobilisation intervention

Primary outcome

Number of days alive and out of hospital
Time frame: between randomisation and 180 days
Any days spent in rehabilitation or a nursing home counted as days in hospital

7 secondary outcomes

All-cause mortality
Time frame: From date of randomisation up to180days.
Time from randomisation until death
Time frame: From date of randomisation unitl date of death from all cause, censored at 180days
Ventilator-free days
Time frame: From date of randomisation until day 28
ICU-free days
Time frame: From date of randomisation until day 28
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time frame: Assessed at 180days
Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Assessed at 180days
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)
Time frame: Assessed at 180days

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 18 Dec 2023.
Background: PubMed 26968024Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.
Background: PubMed 27864615Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
Background: PubMed 27707476Iwashyna TJ, Hodgson CL. Early mobilisation in ICU is far more than just exercise. Lancet. 2016 Oct 1;388(10052):1351-1352. doi: 10.1016/S0140-6736(16)31745-7. No abstract available.
Derived from this study: PubMed 40439527Higgins AM, Lee YY, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Hodgson CL; Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Study Investigators. The Cost-Effectiveness of Early Active Mobilization During Mechanical Ventilation in the ICU: An Economic Evaluation Alongside the Treatment of Mechanically Ventilated Adults With Early Activity and Mobilization (TEAM) Trial. Crit Care Med. 2025 Sep 1;53(9):e1725-e1735. doi: 10.1097/CCM.0000000000006715. Epub 2025 May 27.
Derived from this study: PubMed 39826257Broadley T, Serpa Neto A, Bailey M, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Hurford S, Iwashyna TJ, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ, Higgins AM, Hodgson CL; TEAM Trial Investigators. Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial. Aust Crit Care. 2025 May;38(3):101156. doi: 10.1016/j.aucc.2024.101156. Epub 2025 Jan 17.
Derived from this study: PubMed 38046085Presneill JJ, Bellomo R, Brickell K, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna T, Neto AS, Nichol A, Schaller SJ, Sivasuthan J, Tipping C, Webb S, Young P, Hodgson CL; TEAM Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Crit Care Resusc. 2023 Oct 18;23(3):262-272. doi: 10.51893/2021.3.OA3. eCollection 2021 Sep 6.
Derived from this study: PubMed 36286256TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.
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.

Carol Hodgson, Prof study chair

ANZIC-RC

49 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 10 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Australia, United Kingdom, New Zealand, Ireland, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of days alive and out of hospital (time frame: between randomisation and 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03133377, which also lists 7 linked publications.

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 18 Dec 2023.