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Trial registered on ANZCTR


Registration number
ACTRN12614000258651
Ethics application status
Approved
Date submitted
25/02/2014
Date registered
11/03/2014
Date last updated
30/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of standard communication and antimicrobial stewardship on time to appropriate antimicrobial therapy in blood stream infections
Scientific title
In patients with a positive blood culture, does standard communication from the microbiology laboratory plus Antimicrobial Stewardship Team review improve the time to appropriate antimicrobial therapy when compared to standard laboratory communication methods?
Secondary ID [1] 284154 0
Nil known
Universal Trial Number (UTN)
U1111-1153-5612
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positive blood cultures 291238 0
Condition category
Condition code
Infection 291583 291583 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will recieve both standard care (see comparator/control treatment) plus antimicrobial stewardship team review. Antimicrobial Stewardship Team review will occur on the same day (ie. within 12 hours) of the positive blood culture being announced at the weekday Microbiology Laboratory meeting.

Antimicrobial Stewardship Team Review: This refers to a focused review of the patients medical record and relevant pathology/microbiology by an Infectious Diseases Physician, an Antimicrobial Stewardship Pharmacist and Infectious Diseases Registrar. The patient is not clinically reviewed during this process. Recommendations for antimicrobial therapy are dicussed with the treating unit and documented in the medical record. The clinical decision to alter antimicrobial therapy remains with the treating unit.
Intervention code [1] 288846 0
Treatment: Other
Comparator / control treatment
Standard care: The current standard of care when blood cultures flag positive is that the microbiology laboratory (usually the Microbiology Registrar or a Laboratory Scientist after hours) calls the resident caring for the patient. Clinical advice may be provided at this time, however this advice does not include a review of the medical record.

Control group
Active

Outcomes
Primary outcome [1] 291534 0
Time to ‘appropriate’ antimicrobial therapy following blood culture positivity in the microbiology laboratory

Appropriateness of antimicrobial therapy will be analysed based on microbiological activity and clinical appropriateness. This will be assessed by an independent, blinded panel of infectious diseases physicians.

Active antimicrobial therapy: refers to an antimicrobial agent with a spectrum of activity that will be active against the isolated organism. The spectrum of activity of ‘active’ antimicrobial therapy may differ to that of ‘appropriate’ antimicrobial therapy.

Appropriate antimicrobial therapy is defined as antimicrobial therapy that meets the following criteria:
- Has an adequate spectrum of activity against the pathogen
- Correct dosing regimen
- Appropriate route of administration
- Considers the clinical picture of the patient (e.g. adverse drug reactions, additional microbiological culture results)
If any of the above criteria are not met, the antimicrobial therapy will be deemed inappropriate.
Timepoint [1] 291534 0
24 hours, 48 hours and 72 hours after taking blood cultures. Time of blood cultures being taken will be regarded as time 'zero'
Secondary outcome [1] 306987 0
Time to ‘active’ antimicrobial therapy. This will be assessed by an independent, blinded panel of infectious diseases physicians.

Active antimicrobial therapy: refers to an antimicrobial agent with a spectrum of activity that will be active against the isolated organism. The spectrum of activity of ‘active’ antimicrobial therapy may differ to that of ‘appropriate’ antimicrobial therapy.
Timepoint [1] 306987 0
24 hours, 48 hours and 72 hours after taking blood cultures. Time of blood cultures being taken will be regarded as time 'zero'
Secondary outcome [2] 306989 0
Time to appropriate antibiotic defined as correct agent, dose, route of administration, narrowest spectrum for diagnosis.
Timepoint [2] 306989 0
A specific time point wasn't used as time to appropriate therapy was considered as a continuous (time to event) outcome.
Secondary outcome [3] 306992 0
Mortality
Timepoint [3] 306992 0
In-hospital

Eligibility
Key inclusion criteria
First episode positive blood culture detected by BacT/ALERT (Registered Trademark) 3D automated blood culture system
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted under the Haematology, ID, Respiratory, Burns or Intensive Care Units where existing Infectious Diseases (ID) liaison services exist
Patients who are currently receiving a formal ID consultation at the time of blood culture positivity
Patients admitted at Sandringham or Caulfield Hospitals (as Antimicrobial Stewardship Team review does not currently operate routinely at these sites)
Outpatients
Patients in the emergency department/short stay unit who are discharged within 24 hours of blood culture positivity
Patients transferred from a hospital outside of Alfred Health with a blood stream infection
Patients transferred to another hospital within 24 hours of blood culture positivity
Patients with antimicrobial agents already entered into Guidance MS
Patients admitted under a medical unit where their treating physician is an ID physician
Patients considered to be palliative and not for further medical intervention

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)
Patients will be prospectively identified by the Antimicrobial Stewardship Pharmacist at the daily (Monday – Friday) microbiology laboratory meeting, with subsequent randomisation according to a pre-determined randomisation structure.
Patients who are identified with a positive blood culture on weekends will be identified at the Monday microbiology laboratory meeting
As current standard of care is for the Antimicrobial Stewardship Team to review patients entered into Guidance MS (Registered Trademark), patients will be stratified for inclusion into the study according to a pre-determined study flowchart
Allocation concealment was undertaken using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Sealed ppaque envelopes containing the randomisation allocation were filled by a research assistant not involved in the trial.
Upon identification of potentially suitable patients, the Antimicrobial Stewardship Pharmacist screens the patient for elligibility for the trial. If the patient is suitable, the randomisation envelope is then opened to determine allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is estimated that an enrolment of 80 patients in each arm (ie. total of 160 patients) will have 80% power to show a significant difference in the time to appropriate antimicrobial therapy, assuming approximately 20% of patients are on inappropriate antimicrobial therapy 24 hours after blood culture positivity without Antimicrobial Stewardship Team review and 4% of patients are on inappropriate antimicrobial therapy with Antimicrobial Stewardship Team review and a two-sided type I error of 0.05.

Time to event data, including time to species identification and time to appropriate antimicrobial therapy, will be compared between study arms using the Log rank test. A multivariate analysis for time to appropriate antimicrobial therapy will be performed adjusting for severity of illness (measured using the MEDS score) using a Cox proportional hazards model. Categorical outcomes, such as proportion of patients on appropriate antimicrobial therapy at the time blood cultures are positive and adherence with recommendations will be compared using the Fisher's exact test. Other continuous measures, such as additional resource use, will be summarised using descriptive statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2014
Actual
27/02/2014
Date of last participant enrolment
Anticipated
31/07/2014
Actual
29/12/2015
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2131 0
The Alfred - Prahran
Recruitment hospital [2] 6586 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 7820 0
3181 - Prahran
Recruitment postcode(s) [2] 14193 0
3169 - Clayton South

Funding & Sponsors
Funding source category [1] 288779 0
Self funded/Unfunded
Name [1] 288779 0
Country [1] 288779 0
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commerical Rd
Prahran
VIC, 3181
Country
Australia
Secondary sponsor category [1] 287477 0
University
Name [1] 287477 0
Monash University
Address [1] 287477 0
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
381 Royal Parade
Parkville
VIC 3052
Country [1] 287477 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290626 0
Alfred Ethics Committee
Ethics committee address [1] 290626 0
Ethics committee country [1] 290626 0
Australia
Date submitted for ethics approval [1] 290626 0
Approval date [1] 290626 0
23/01/2013
Ethics approval number [1] 290626 0
490/13
Ethics committee name [2] 290627 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 290627 0
Ethics committee country [2] 290627 0
Australia
Date submitted for ethics approval [2] 290627 0
Approval date [2] 290627 0
06/02/2014
Ethics approval number [2] 290627 0
CF14/321 - 2014000117
Ethics committee name [3] 295856 0
Monash Health Ethics Committee
Ethics committee address [3] 295856 0
Ethics committee country [3] 295856 0
Australia
Date submitted for ethics approval [3] 295856 0
10/11/2014
Approval date [3] 295856 0
19/11/2014
Ethics approval number [3] 295856 0
14432XL

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

Contacts
Principal investigator
Name 46386 0
Prof Michael Dooley
Address 46386 0
The Alfred Hospital,
55 Commercial Road
Prahran, VIC, 3181
Country 46386 0
Australia
Phone 46386 0
+61 3 907 62061
Fax 46386 0
Email 46386 0
M.Dooley@alfred.org.au
Contact person for public queries
Name 46387 0
Kelly Cairns
Address 46387 0
The Alfred Hospital,
55 Commercial Road
Prahran, VIC, 3181
Country 46387 0
Australia
Phone 46387 0
+61 3 907 62061
Fax 46387 0
Email 46387 0
K.Cairns@alfred.org.au
Contact person for scientific queries
Name 46388 0
Kelly Cairns
Address 46388 0
The Alfred Hospital,
55 Commercial Road
Prahran, VIC, 3181
Country 46388 0
Australia
Phone 46388 0
+61 3 907 62061
Fax 46388 0
Email 46388 0
K.Cairns@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
EmbaseThe impact of a multidisciplinary antimicrobial stewardship team on the timeliness of antimicrobial therapy in patients with positive blood cultures: A randomized controlled trial.2016https://dx.doi.org/10.1093/jac/dkw285
N.B. These documents automatically identified may not have been verified by the study sponsor.