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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03213990
Registration number
NCT03213990
Ethics application status
Date submitted
5/06/2017
Date registered
11/07/2017
Titles & IDs
Public title
Beta-Lactam InfusioN Group Study
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Scientific title
A Phase III Randomised Controlled Trial of Continuous Beta-lactam Infusion Compared With Intermittent Beta-lactam Dosing in Critically Ill Patients
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Secondary ID [1]
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TGI-CCT254643
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Universal Trial Number (UTN)
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Trial acronym
BLING III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Continuous infusion
Other interventions - Intermittent infusion
Other: Continuous Infusion - The prescribed Beta-lactam is administered by a continuous infusion.
Other: Intermittent infusion - the prescribed Beta-lactam is administered by intermittent infusion over 30 minutes
Other interventions: Continuous infusion
Clinician prescribed beta-lactam antibiotic will be administered via continuous infusion for as long as prescribed whilst in the ICU
Other interventions: Intermittent infusion
Clinician prescribed beta-lactam antibiotic will be administered via intermittent infusion for as long as prescribed whilst in the ICU
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Intervention code [1]
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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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All-cause mortality
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Assessment method [1]
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Patient mortality status assessed at 90 days after randomisation
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Timepoint [1]
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90 Days after randomisation
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Secondary outcome [1]
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Clinical Cure
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Assessment method [1]
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Clinical cure will be defined as the completion of the beta-lactam antibiotic treatment course (on or prior to Day 14) without recommencement of antibiotic therapy within 48 hours of cessation.
Participants discharged from hospital within 14 days following randomisation will be considered to meet the definition of clinical cure. Participants who decease while receiving the antibiotic treatment course or where antibiotic therapy is ceased in the setting of death being deemed imminent and inevitable, will be assessed as not meeting the criteria for clinical cure.
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Timepoint [1]
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Day 14 post randomisation
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Secondary outcome [2]
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New acquisition, colonisation or infection
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Assessment method [2]
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New acquisition, colonisation or infection with an Multi-resistant organism (MRO) or Clostridium difficile diarrhoea
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Timepoint [2]
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up to 14 days post randomisation or hospital discharge, whichever is sooner
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Secondary outcome [3]
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All cause ICU mortality
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Assessment method [3]
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Patient mortality status assessed at ICU discharge
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Timepoint [3]
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up to 90 days
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Secondary outcome [4]
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All cause hospital mortality
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Assessment method [4]
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Patient mortality status assessed at hospital discharge
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Timepoint [4]
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up to 90 days
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Eligibility
Key inclusion criteria
1. Documented site of infection or strong suspicion of infection
2. At the time of the assessment of suitability for the study, the treating physician expects the patient will require treatment in the ICU that extends beyond the next calendar day
3. The treating physician has chosen piperacillin-tazobactam or meropenem to treat the episode of infection
4. The treating physician is uncertain if administration of the chosen antibiotic by intermittent or continuous infusion is superior
5. One or more organ dysfunction entry criteria in the previous 24 hours
* i. Mean arterial pressure < 60 mmHg for at least 1 hour
* ii. Vasopressors required for > 4 hours
* iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour
* iv. Serum creatinine concentration > 220 µmol/L
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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. Age less than 18 years
2. Receipt of piperacillin-tazobactam or meropenem for more than 24 hours during current infectious episode
3. Patients who are known or suspected to be pregnant
4. Patient has a known allergy to piperacillin-tazobactam or meropenem or penicillin
5. Receiving renal replacement therapy at the time of assessment for eligibility
6. The treating physician is not committed to provision of advanced life-support, including mechanical ventilation, dialysis and vasopressor administration, for at least the next 48 hours
7. Death is deemed imminent and inevitable
8. The patient has previously been enrolled in BLING III
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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
NA
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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
26/03/2018
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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
29/06/2023
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Sample size
Target
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Accrual to date
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Final
7203
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Bankstown Hospital - Bankstown
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Blacktown Hospital - Blacktown
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Royal Prince Alfred Hospital - Camperdown
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St Vincents Hosptial - Darlinghurst
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Gosford Hospital - Gosford
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John Hunter Hospital - New Lambton Heights
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Royal North Shore Hospital - Saint Leonards
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St George Hospital - Sydney
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Royal Darwin Hospital - Casuarina
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The Wesley Hospital - Auchenflower
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Royal Brisbane and Women's Hospital - Brisbane
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Logan Hospital - Meadowbrook
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Redcliffe Hospital - Redcliffe
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Gold Coast University Hospital - Southport
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Austin Hospital - Heidelberg
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Royal Melbourne Hospital - Melbourne
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2200 - Bankstown
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2148 - Blacktown
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2050 - Camperdown
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2010 - Darlinghurst
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2250 - Gosford
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2305 - New Lambton Heights
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2065 - Saint Leonards
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2145 - Westmead
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0811 - Casuarina
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4066 - Auchenflower
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4510 - Caboolture
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4131 - Meadowbrook
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4020 - Redcliffe
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4215 - Southport
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4102 - Woolloongabba
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- Adelaide
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5112 - Elizabeth Vale
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7001 - Hobart
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3550 - Bendigo
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3128 - Box Hill
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3220 - Geelong
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3084 - Heidelberg
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3050 - Melbourne
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Recruitment outside Australia
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Belgium
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Anderlecht
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Romford
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Salford
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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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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Other collaborator category [2]
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Other
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Name [2]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out whether continuous infusion of beta-lactam antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health advantages to patients or if there is no difference. The investigators will be looking to see whether patients receiving beta-lactams via one administration method or the other have a better chance of recovering from their illness. They will also be looking at long term outcomes such as quality-of-life and healthcare resource use. 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. Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in patients with sepsis and septic shock. Currently, beta-lactam antibiotics are most commonly given to patients be intermittent infusions, that is, given at regular intervals throughout 24 hours. New research suggests that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic concentrations in the blood remain more consistent and may be more effective at killing bacteria. However, the benefit to the patient by giving beta-lactams via continuous infusion has not been tested in a high-quality, large clinical trial.
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Trial website
https://clinicaltrials.gov/study/NCT03213990
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Trial related presentations / publications
Lipman J, Brett SJ, De Waele JJ, Cotta MO, Davis JS, Finfer S, Glass P, Knowles S, McGuinness S, Myburgh J, Paterson DL, Peake S, Rajbhandari D, Rhodes A, Roberts JA, Shirwadkar C, Starr T, Taylor C, Billot L, Dulhunty JM. A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent beta-lactam antibiotic infusion in critically ill patients with sepsis: BLING III. Crit Care Resusc. 2019 Mar;21(1):63-68.
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Public notes
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Contacts
Principal investigator
Name
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Jeffrey Lipman
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Address
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The George Institute
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Yet to be decided
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: PKPD Substudy
https://cdn.clinicaltrials.gov/large-docs/90/NCT03213990/Prot_000.pdf
Study protocol
Study Protocol: BLING III PKPD substudy protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT03213990/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT03213990/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03213990