RecruitingACTRN12622001173785

Epidemiology and Management of invasive infections among people who Use drugs (EMU)

Sponsor

Monash University

Enrollment

146 participants

Start Date

Apr 5, 2022

Study Type

Observational

Conditions

Osteomyelitis Injecting drug use Bacteraemia Epidural abscess

Summary

Among people who inject drugs (PWIDs) with invasive infections, completion of planned antimicrobial therapy is likely to be an important predictor of patient outcome. The probability of completion of planned therapy may vary based on the model of care. Our aims are to determine the current burden, management and outcomes of invasive infections and the impact of currently available models of care on confirmed completion of planned antimicrobials for PWID admitted to hospital with invasive infections. We will enrol adults at least 18 years old with current injecting drug use (defined as within previous six months) admitted to hospital for management of a proven or suspected acute infection. EMU will be performed as a multi-centre prospective cohort study with two separate but related components. EMU-Audit will collect de-identified standard of care information regarding patient admission, demographics, management and outcomes. EMU-Cohort will enrol a subset of participants involved in EMUAudit who consent to 30- and 90-day follow up and data linkage. We hypothesise that in PWID with invasive infections, community-based treatment is superior to inpatient management alone for confirmed completion of planned antimicrobials.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People who inject drugs are at serious risk of developing severe, life-threatening infections — including infections of the heart valves, spine, bones, and joints. When these infections occur, they require prolonged courses of antibiotics, often given intravenously, and completing the full course of treatment is critical for a good outcome. However, many of these patients face barriers to completing treatment when discharged from hospital. This study is observing how these serious infections are currently managed across multiple Australian hospitals and what affects whether patients complete their planned antibiotic treatment. It involves two components: an audit collecting anonymised data on all admitted patients who inject drugs and have invasive infections, and a separate cohort study following consenting participants for 30 and 90 days after discharge to track their recovery. You may be eligible if you are 18 or older, have injected drugs within the last six months, and are being admitted to hospital for a serious bacterial or fungal infection such as endocarditis (heart valve infection), bone infection, spinal abscess, or blood infection. You would not be eligible for the cohort follow-up portion if you are unable to give consent or cannot communicate in English, or do not have access to a telephone.

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Interventions

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.