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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04494789
Registration number
NCT04494789
Ethics application status
Date submitted
19/07/2020
Date registered
31/07/2020
Date last updated
18/01/2024
Titles & IDs
Public title
Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS
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Scientific title
A Phase II Open Label Randomised Controlled Clinical Trial of Different Dosing Regimens of Fludrocortisone in Septic Shock With Assessment of Temporal Changes in Hormonal, Inflammatory, and Genetic Markers of Vascular Responsiveness
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Secondary ID [1]
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GI-CC35837377
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Universal Trial Number (UTN)
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Trial acronym
FluDReSS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critically Ill
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Septic Shock
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fludrocortisone Acetate
Treatment: Drugs - Fludrocortisone Acetate
Treatment: Drugs - Fludrocortisone Acetate
Other interventions - Standard Therapy
Active Comparator: Fludrocortisone dosing regime: 24hrs - Receive 50mcg doses of fludrocortisone every 24hrs
Active Comparator: Fludrocortisone dosing regime: 12hrs - Receive 50mcg doses of fludrocortisone every 12hrs
Active Comparator: Fludrocortisone dosing regime: 6hrs - Receive 50mcg doses of fludrocortisone every 6hrs
Placebo Comparator: Control Arm - Receives standard treatment without fludrocortisone dosing regime
Treatment: Drugs: Fludrocortisone Acetate
50mcg
Treatment: Drugs: Fludrocortisone Acetate
100mcg
Treatment: Drugs: Fludrocortisone Acetate
200mcg
Other interventions: Standard Therapy
NO Fludrocortisone
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to resolution of shock by Intervention group allocation
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Assessment method [1]
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To the assess the time it takes for shock to resolve in each intervention arm
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Timepoint [1]
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7 DAYS
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Primary outcome [2]
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Time to resolution of shock and Fludrocortisone Levels
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Assessment method [2]
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Assess the levels of fludrocortisone in the interventional groups at time of resolution of shock
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Timepoint [2]
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7 days
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Primary outcome [3]
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Vasopressor Responsiveness by Intervention group allocation
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Assessment method [3]
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Area under the curve of vasopressor dose in each intervention arm
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Timepoint [3]
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7 days
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Primary outcome [4]
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Vasopressor Responsiveness and Fludrocortisone Levels
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Assessment method [4]
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Area under the curve of vasopressor dose associated with fludrocortisone levels
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Timepoint [4]
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7 days
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Secondary outcome [1]
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Recurrence of shock
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Assessment method [1]
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Time between a new episode of shock after reversal of the initial episode
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Timepoint [1]
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censored at day 28
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Secondary outcome [2]
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Ventilation free days
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Assessment method [2]
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Number of Days that are without ventilation during admission
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Timepoint [2]
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censored at day 28
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Secondary outcome [3]
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ICU and hospital length of Stay
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Assessment method [3]
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Total number of days in ICU and in hospital for the index admission
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Timepoint [3]
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censored at day 28
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Secondary outcome [4]
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ICU and hospital mortality
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Assessment method [4]
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The number of deaths that are recorded in participants and the location of the deaths when in hospital - ICU or ward. This will include cause of death
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Timepoint [4]
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censored at day 28
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Secondary outcome [5]
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Delta SOFA Score
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Assessment method [5]
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Baseline SOFA score to SOFAmax - numerical calculation based on scoring system of each participant during their admission
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Timepoint [5]
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censored at day 28
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Secondary outcome [6]
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Maximal SOFA score
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Assessment method [6]
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Maximum SOFA score for each participant during their admission
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Timepoint [6]
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censored at day 28
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Secondary outcome [7]
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Superinfection
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Assessment method [7]
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This is the number of new infections that occur >48hrs after commencing study drug
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Timepoint [7]
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censored at day 28
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Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Documented site, or strong suspicion of infection with 2 of the 4 clinical signs of
inflammation:
1. Core temperature > 38oC or < 35oC
2. Heart rate > 90bpm
3. Respiratory rate > 20bpm, or PaCO2 < 32mmHg, or mechanical ventilation
4. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils\
3. Being treated with Hydrocortisone at a daily dose of 200mg / day as adjunctive
treatment for sepsis
4. Being treated with mechanical ventilation at the time of randomisation (includes mask
BiPAP/CPAP)
5. Being treated with continuous vasopressors or inotropes to maintain a systolic blood
pressure > 90mmHg, or mean arterial pressure > 60mmHg or a MAP target set by the
treating clinician for maintaining perfusion
6. Administration of vasopressors or inotropes for > 4 hours and present at time of
randomisation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Met all inclusion criteria more than 24 hours ago
2. Patients taking long term corticosteroids or fludrocortisone
3. Patients with systemic fungal infection
4. Death is deemed inevitable or imminent during this admission and either the attending
physician, patient or surrogate legal decision maker is not committed to active
treatment
5. Patient unable to receive enteral medication
6. Death from underlying disease likely within 90 days
7. Patient has been previously enrolled in the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2023
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Sample size
Target
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Accrual to date
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Final
155
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Blacktown Hospital - Sydney
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Recruitment hospital [2]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [3]
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Royal Brisbane Women's Hospital - Brisbane
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Recruitment hospital [4]
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Wesley Hospital - Brisbane
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Recruitment hospital [5]
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Gold Coast University Hospital - Gold Coast
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Recruitment hospital [6]
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Mater Misericordiae - Raymond Terrace
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Recruitment hospital [7]
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Princess Alexandra Hospiital - Woolloongabba
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Recruitment hospital [8]
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Queen Elizabeth II Hospital - Adelaide
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Recruitment hospital [9]
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Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- Gold Coast
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Recruitment postcode(s) [4]
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4101 - Raymond Terrace
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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- Adelaide
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Recruitment postcode(s) [7]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the most suitable dose of Fludrocortisone in
reversal of sepsis and shock associated with sepsis in patients who are admitted to the ICU.
The investigators will be looking to see whether patients receiving Fludrocortisone at
different doses recover quicker and spend less time in hospital and in ICU, and to understand
the reasons why this happens at certain doses.
Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the
bloodstream from a site of infection. In some people, the infection can progress to sepsis
and septic shock where the functions of organs in the body are affected. Patients suffering
from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they
are prescribed antibiotics as standard therapy, as well as other therapies to support the
functions of the body.
Fludrocortisone is a steroid that has previously shown to be beneficial to help in shock in
patients in ICU, but more information is required about the exact dose that is required to
achieve this. This has been shown by previous research.
However, the exact role of Fludrocortisone and the best dose has not been studied adequately
to date as well as the ways in how it works within the body. The study aims to look tat the
dose and the way it works.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04494789
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James Walsham, MB ChB, MRCP, FCICM.
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Address
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Princess Alexandra Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04494789
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