Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001173785
Ethics application status
Approved
Date submitted
17/08/2022
Date registered
30/08/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
30/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidemiology and Management of invasive infections among people who Use drugs (EMU)
Scientific title
Epidemiology and Management of invasive infections among people who Use drugs (EMU)
Secondary ID [1] 307728 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EMU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injecting drug use 327261 0
Infective endocarditis 327263 0
Osteomyelitis 327264 0
Bacteraemia 327265 0
Epidural abscess 327323 0
Condition category
Condition code
Infection 324425 324425 0 0
Studies of infection and infectious agents
Mental Health 324426 324426 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The EMU study is a prospective multi-centre cohort study of people who inject drugs (PWID) admitted to Australian public hospitals for the treatment of invasive infections. Participating hospitals will continue their current management strategies for invasive infections in PWID and participants will be stratified according to the management strategy received. The exposure of interest will be categorised based on the model of care used to deliver antimicrobial therapy, categorised as: (1) inpatient intravenous antimicrobials; (2) outpatient parenteral antimicrobial therapy (OPAT); (3) early oral antimicrobial therapy; or (4) long acting lipoglycopeptide.

The EMU study will be performed as two components to optimise information about the epidemiology of invasive infections in PWID. EMU-Audit will collect non-identifiable information regarding admissions of PWID with invasive infections including infective aetiology, participant demographics, management and outcomes. As EMU-Audit will only collect standard of care information already recorded in medical records, this arm of the study will be performed with a waiver of patient consent. There will be no active involvement of participants in EMU-Audit as only data from medical records will be collected for the study. The event of interest will be the admission for treatment of invasive infection; as such, the duration of observation of participants in EMU-Audit will be from hospital admission for treatment of their invasive infection to discharge. This data will all be collected prospectively during the participants admission.

EMU-Cohort will occur with a subset of participants involved in EMU-Audit who consent to 30- and 90-day follow up and data linkage. This will enable follow up and data linkage to occur in participants from EMU-Audit who are willing to consent to follow up. Eligible participants identified as part of EMU-Audit will be approached by study investigators not involved in the patients clinical care and provided with a participant information consent form (PICF) and verbal information about the study activities, risks and benefits. Participation in EMU-Cohort would entail: (1) An entry interview with research staff which may collect more detailed information regarding their hospital admission, past medical history including any previous invasive infections and drug history. The Australian Hospital Patient Experience Question Set (AHPEQS) will also be completed at this time to gather quantitative data about the admission experience. This interview may occur face-to-face whilst the participant is an inpatient or via private phone call, whichever the participant is more comfortable with. The entry interview takes less than one hour to complete. (2) Potential contact on a private social media messaging platform to arrange two follow up calls following completion of treatment from research staff (day 30 and day 90 post discharge). (3) Two follow up calls at 30- and 90-days post discharge. These calls would collect information about completion of any treatment, and any requirement for readmission into hospital. The AHPEQS would also be re-completed to compare quantitative data about the previous admission experience. These calls would occur to numbers provided to research staff and at a time agreed on by both the participant and research staff. These calls take roughly 20 minutes to complete. (4) The opportunity to be involved in data linkage; participants would be provided the ability separately to consent to that process. For participants who consent to be involved in data linkage, the Centre for Victorian Data Linkage (CVDL) will link cohort data from participating Victorian sites to statewide datasets for emergency department presentations (Victorian Emergency Minimum Dataset - VEMD), hospital admissions (Victorian Admitted Episodes Dataset - VAED), and mortality status (Victorian Death Index). This will be used used to analyse 30-day and 90-day mortality and readmission rates as well as medium and long-term outcomes.
Intervention code [1] 324203 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332242 0
Confirmed completion of planned antimicrobial therapy.
For EMU-Audit participants this will be obtained from the documented outcome in the medical record from that episode. For EMU-Cohort participants this information will be obtained from the 30- and 90-day follow up interviews.
Timepoint [1] 332242 0
For participants enrolled in EMU-Audit: on discharge from hospital.
For participants enrolled in EMU-Cohort: 90-days post discharge.
Secondary outcome [1] 412677 0
Length of hospital admission in days
This information will be obtained from the medical record of the admission for treatment of invasive infection.
Timepoint [1] 412677 0
On discharge from hospital for both participants enrolled in EMU-Audit and EMU-Cohort
Secondary outcome [2] 412678 0
Mortality during admission for invasive infection
This information will be obtained from the medical record of the admission for treatment of invasive infection.
Timepoint [2] 412678 0
On discharge from hospital for both participants enrolled in EMU-Audit and EMU-Cohort
Secondary outcome [3] 412679 0
Surgery requirement
This information will be obtained from the medical record of the admission for treatment of invasive infection.
Timepoint [3] 412679 0
On discharge from hospital for both participants enrolled in EMU-Audit and EMU-Cohort
Secondary outcome [4] 412680 0
Intensive care unit admission requirement including length of stay and intubation requirement
This information will be obtained from the medical record of the admission for treatment of invasive infection.
Timepoint [4] 412680 0
On discharge from hospital for both participants enrolled in EMU-Audit and EMU-Cohort
Secondary outcome [5] 412682 0
Unplanned discharge from either inpatient or OPAT admission; including patients discharged as a patient directed discharge
This information will be obtained from the medical record of the admission for treatment of invasive infection.
Timepoint [5] 412682 0
On discharge from hospital for both participants enrolled in EMU-Audit and EMU-Cohort
Secondary outcome [6] 412683 0
For participants enrolled in EMU-Cohort: patient reported experience measured through the Australian Hospital Patient Experience Question Set (AHPEQS)
Timepoint [6] 412683 0
On discharge, 30-days and 90-days post discharge
Secondary outcome [7] 412684 0
For participants enrolled in EMU-Cohort: Readmission for infection or treatment-related complications and unplanned readmission for any reason.
This information will be obtained from participant reports of readmission in the 30- and 90-day follow up interviews. For participants who have consented to data linkage, the Centre for Victorian Data Linkage will also be used to link cohort data to facilitate unique post-discharge follow-up data for emergency department presentations (Victorian Emergency Minimum Dataset - VEMD) and hospital admissions (Victorian Admitted Episodes Dataset - VAED).
Timepoint [7] 412684 0
30- and 90-days post discharge.
Secondary outcome [8] 412685 0
For participants enrolled in EMU-Cohort: loss to follow up as defined as a participant unable to be contacted for follow up interviews
This data will be obtained at the 30- and 90-day interviews if participants are unable to be contacted.
Timepoint [8] 412685 0
90-days post discharge
Secondary outcome [9] 412686 0
For patients enrolled in EMU-Cohort: Re-admission free survival
This information will be obtained from participant reports of readmission in the 30- and 90-day follow up interviews. For participants who have consented to data linkage, the Centre for Victorian Data Linkage will also be used to link cohort data to facilitate unique post-discharge follow-up data for emergency department presentations (Victorian Emergency Minimum Dataset - VEMD), hospital admissions (Victorian Admitted Episodes Dataset - VAED), and mortality status (Victorian Death Index).
Timepoint [9] 412686 0
30- and 90-days post discharge

Eligibility
Key inclusion criteria
Subjects will be eligible for this study if they:
*Are adult patients aged at least 18 years
*Have a history of current intravenous drug use (IDU). Current IDU defined as use within six months prior to admission.
*Are admitted to hospital for management of invasive bacterial or fungal infection (proven or presumed).

Invasive infections are defined by treating physician diagnosis (proven or presumed) of the following infections:
*Infective endocarditis
*Epidural abscess
*Bone and join infection (including osteomyelitis, septic arthritis, or prosthetic joint infection)
*Other deep abscess (excluding acute bacterial skin and skin structure infections (ABSSSI) but including soft tissue such as muscle/ lung/ liver/ spleen/ cerebral with no evidence of infective endocarditis)
*Bacteraemia or candidaemia not otherwise specified (excluding infective endocarditis)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EMU-Audit:
*Patients with acute bacterial skin and skin structure infections (ABSSSI) only and no evidence of invasive infection
*Patients admitted for management of viral infection only (HAV/ HBV/ HCV/ HIV) and no evidence of bacterial or fungal infection
*Patients admitted for management of viral or bacterial meningitis only with no evidence of above invasive infections
*Patients admitted for a reason unrelated to an acute infection (such as trauma), who subsequently develop an invasive infection

EMU-Cohort:
As per exclusion criteria for EMU-Audit patients AND
*Refusal to participate
*Patient unable to give informed consent including if not fluent in English to be able to understand the PICF and participate in the consent process
*No access to landline or mobile telephone for follow up

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary comparison of interest in the EMU study is between the main currently utilised models of care - inpatient intravenous antimicrobials and outpatient parenteral antimicrobial therapy. Assuming 80% power and an alpha of 0.05, 73 participants per treatment arm will allow the detection of a difference between a confirmed completion rate of 65% in the inpatient treatment group and 85% in the OPAT treatment group. Therefore, 146 participants will be recruited to EMU-Audit. It is expected that the number of eligible participants in the early oral antimicrobial therapy arm and long acting lipoglycopeptide arms will be much smaller than the inpatient intravenous antimicrobial and OPAT arms. As such, we have not powered the EMU study for these arms and instead will include these results for descriptive purposes and to inform design of future studies and models of care.

Primary outcome will be the comparison of confirmed completion of planned antimicrobials by group. Groups are defined by participation in existing models of care for the treatment of infections in PWID.
The impact of model of care on completion of planned antimicrobial will be determined using logistic regression with random effects for hospital and adjusted for confounders such as:
-Active injecting drug use (within the last three months)
-Current homelessness
-Predominant injecting substance – opioid versus amphetamine
-On opioid replacement therapy (methadone/ suboxone/ buprenorphine)

For secondary outcomes, dichotomous variables will be investigated using logistic regression with random effects for hospital. Continuous variables will be investigated using linear regression with random effects for hospital.
The frequency of confirmed completion in patients who received a patient directed discharge (PDD) will be assessed as a subgroup. A sensitivity analysis will be performed to estimate the effect on completion of patients who received a PDD as an altered management plan. A secondary analysis of the primary outcome will include time to event analysis and cox model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
146
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22935 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 38241 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311973 0
Hospital
Name [1] 311973 0
Department of Infectious Diseases, Alfred Health
Country [1] 311973 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Central Clinical School and Department of Infectious Diseases
85 Commercial Road
Melbourne, Victoria
3004
Country
Australia
Secondary sponsor category [1] 313577 0
None
Name [1] 313577 0
Address [1] 313577 0
Country [1] 313577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311402 0
Alfred Hospital
Ethics committee address [1] 311402 0
Ethics committee country [1] 311402 0
Australia
Date submitted for ethics approval [1] 311402 0
23/08/2021
Approval date [1] 311402 0
14/10/2021
Ethics approval number [1] 311402 0
Project number 78815; local reference project 529/21

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

Contacts
Principal investigator
Name 120970 0
A/Prof Andrew Stewardson
Address 120970 0
Department of Infectious Diseases
Alfred Health and Monash University
55 Commercial Road
Melbourne, Victoria
3004
Country 120970 0
Australia
Phone 120970 0
+61 0390763009
Fax 120970 0
Email 120970 0
[email protected]
Contact person for public queries
Name 120971 0
Lucy Attwood
Address 120971 0
Department of Infectious Diseases
Alfred Hospital
55 Commercial Road
Melbourne, Victoria
3004
Country 120971 0
Australia
Phone 120971 0
+61 0390766908
Fax 120971 0
Email 120971 0
[email protected]
Contact person for scientific queries
Name 120972 0
Lucy Attwood
Address 120972 0
Department of Infectious Diseases
Alfred Hospital
55 Commercial Road
Melbourne, Victoria
3004
Country 120972 0
Australia
Phone 120972 0
+61 0390766908
Fax 120972 0
Email 120972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Contact can be made regarding requests for de-identified data from the EMU study to be made available in the future for collaborative research questions. Such requests must be authorised by the principal investigator and the appropriate Human Research Ethics Committees.
When will data be available (start and end dates)?
Contact can be made regarding requests from data following publication of the EMU study with no end date currently determined.
Available to whom?
Contact can be made by researchers researchers who provide a methodologically sound proposal for future collaborative research questions with the assessment made on a case-by-case basis by the principal investigator.
Available for what types of analyses?
Analysis requests for any research purpose will be assessed on an individual basis by the principal investigator.
How or where can data be obtained?
Access to data is subject to approval by the Principal Investigator, A/Prof Stewardson. Data requests can be made via email at [email protected]


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
EmbaseEpidemiology and Management of invasive infections among people who Use drugs (EMU): protocol for a prospective, multicentre cohort study.2023https://dx.doi.org/10.1136/bmjopen-2022-070236
N.B. These documents automatically identified may not have been verified by the study sponsor.