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Trial registered on ANZCTR


Registration number
ACTRN12618000116224
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
29/01/2018
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of an antimicrobial stewardship team on the appropriateness of antimicrobial
therapy in sepsis
Scientific title
The impact of an antimicrobial stewardship team on the appropriateness of antimicrobial
therapy in sepsis
Secondary ID [1] 293766 0
None
Universal Trial Number (UTN)
U1111-1207-6392
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 306160 0
Condition category
Condition code
Infection 305272 305272 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In hospital patients with medical emergency team (MET) calls for suspected sepsis, antimicrobial therapy is currently managed by the admitting, or home, team. Complex cases may be referred to specialist Infectious Diseases (ID) clinicians on request by the treating team. The antimicrobial stewardship (AMS) team (ID physician and pharmacist) currently conduct a post prescription review of a limited patient group, after the prescription of restricted antimicrobial agents or a positive blood culture result. The former group is primarily identified by clinical pharmacists who request review of their patients, but the AMS team also reviews patients on broad spectrum antimicrobial agents identified by other means. This AMS review is a focused review of medical records, pathology results and clinical notes, but does not include a clinical or physical review of the patient. The AMS team then make recommendations about antimicrobial therapy to the treating team.
Currently, patients with MET calls for suspected sepsis are not routinely seen by the AMS team, despite the use of broad-spectrum antimicrobial agents. Many of these patients are not flagged to the AMS team via the current practice, or referral via current notification mechanisms is often delayed.
The intervention will be ongoing standard care as above, as well as an expert ID AMS review at 48 hours after a MET call for suspected sepsis.
Intervention code [1] 300021 0
Treatment: Drugs
Comparator / control treatment
This study will enroll patients with MET calls for suspected sepsis who would otherwise not be seen by an AMS team. Control patients will continue to receive standard care and management by the treating team as above, which does not currently involve an AMS review for this patient group.

Control patients who are later referred for an AMS review by the treating team will be reviewed as standard care, but will be excluded for the purpose of this study.
Control group
Active

Outcomes
Primary outcome [1] 304425 0
Appropriateness of antimicrobial therapy, as determined by a panel of blinded ID physicians. This will be assessed by review of medical records, pathology results and clinical notes.
Timepoint [1] 304425 0
72 hours post MET call
Secondary outcome [1] 341912 0
Duration of antimicrobial therapy, assessed by review of medical records
Timepoint [1] 341912 0
Hospital discharge or in-hospital death
Secondary outcome [2] 341913 0
Admission to ICU, assessed by review of medical records
Timepoint [2] 341913 0
Hospital discharge or in-hospital death
Secondary outcome [3] 341914 0
Sepsis-related mortality, assessed by review of medical records
Timepoint [3] 341914 0
Hospital discharge or in-hospital death
Secondary outcome [4] 341915 0
All-cause mortality
Timepoint [4] 341915 0
Hospital discharge or in-hospital death

Eligibility
Key inclusion criteria
-Patients with MET calls for suspected sepsis, as identified by Riskman® reports (hospital risk management system)
-First MET call only during the study period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients under the care of an ID physician
-Patients who have already been seen by AMS post MET call, or will be seen on the day of randomisation as standard care (i.e. patients with electronic alerts for restricted antimicrobials or positive blood cultures)
-Patients admitted to the Intensive Care Unit (ICU) within 48 hours post MET call
-Patients with a limitation of care order prohibiting active treatment of sepsis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient allocation will be concealed by sequentially numbered, opaque envelopes sealed by an independent research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient allocation will be determined by computer-generated randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
To detect a difference in antimicrobial appropriateness at 72 hours between 50% in the control group and 80% in the intervention group with an a of 0.05 and 80% power, 45 patients are required in each arm of the study. Due to the limited size of the pilot study used to guide sample size calculations, as well as to allow for patient loss, this number will be inflated to enrol approximately 60 patients in each arm.

Statistical analysis:
Descriptive statistics will be derived. Demographic characteristics and primary and secondary outcomes will be compared between the control group and intervention group participants. Dichotomous outcome measurements will be compared using a chi2 or Fisher exact test. Continuous variables will require a t test or a Mann-Whitney test as appropriate. A p value < 0.05 will be considered to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2018
Actual
Date of last participant enrolment
Anticipated
15/08/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9736 0
The Alfred - Prahran
Recruitment postcode(s) [1] 18515 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 298382 0
Hospital
Name [1] 298382 0
Alfred Hospital Pharmacy Department
Country [1] 298382 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital Pharmacy Department
Address
55 Commercial Road, Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 297517 0
None
Name [1] 297517 0
Address [1] 297517 0
Country [1] 297517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299376 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 299376 0
Ethics committee country [1] 299376 0
Australia
Date submitted for ethics approval [1] 299376 0
08/11/2017
Approval date [1] 299376 0
18/12/2017
Ethics approval number [1] 299376 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80218 0
Prof Michael Dooley
Address 80218 0
The Alfred, 55 Commercial Rd, Melbourne, VIC, 3004
Country 80218 0
Australia
Phone 80218 0
+61 3 9076 2061
Fax 80218 0
Email 80218 0
m.dooley@alfred.org.au
Contact person for public queries
Name 80219 0
Zohal Rashidzada
Address 80219 0
The Alfred, 55 Commercial Rd, Melbourne, VIC, 3004
Country 80219 0
Australia
Phone 80219 0
+61 3 9076 2061
Fax 80219 0
Email 80219 0
z.rashidzada@alfred.org.au
Contact person for scientific queries
Name 80220 0
Zohal Rashidzada
Address 80220 0
The Alfred, 55 Commercial Rd, Melbourne, VIC, 3004
Country 80220 0
Australia
Phone 80220 0
+61 3 9076 2061
Fax 80220 0
Email 80220 0
z.rashidzada@alfred.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEarly antimicrobial stewardship team intervention on appropriateness of antimicrobial therapy in suspected sepsis: A randomized controlled trial.2021https://dx.doi.org/10.1093/jacamr/dlab097
N.B. These documents automatically identified may not have been verified by the study sponsor.