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PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.

PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06220370
Acronym
PATH
Enrollment
300
Registered
2024-01-23
Start date
2024-03-01
Completion date
2029-03-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial, Infection, Fungal, Infection, Soft Tissue, Injection Site Infection, Invasive Bacterial Infection, Invasive Fungal Infections

Keywords

Antimicrobial therapy, Patient-directed discharge, Injection-related infectious diseases

Brief summary

We seek to characterise the burden and outcomes of and understand the current experience of people who inject drugs admitted to hospital with invasive injecting-related infections, in order to implement and evaluate strategies to improve completion of therapy and reduce patient-directed discharges, with ultimate benefit to the patient and health service.

Detailed description

This study will be conducted as a prospective, observational cohort study of adults admitted with invasive bacterial and fungal infectious diseases. This study will be conducted at multiple hospitals in Australia. Participants will be invited for Screening whilst they are inpatients of the hospital. Participants will be screened for history of injection drug use in the last 6 months and presence of an invasive bacterial or fungal infection. Eligible participants will be treated through standard of care with the applicable treatment. All participants will commence antimicrobial treatment whilst they are inpatients. For participants who are discharged before planned treatment completion, a hospital discharge visit (Early Discharge Electronic Case Report Form \[eCRF\]) will be conducted. Following the end of treatment, participants will be reviewed at 6, 12 and 48-weeks post-enrolment. At follow-up visits, behavioural surveys, health-related quality of life, and experiences with hospital care will be assessed. Individual patient involvement will include four visits over a 12-month period. The duration of the study is anticipated to be 5 years.

Interventions

OTHERObservational

There is no clinical intervention as part of this study. Participants will receive treatment as per their clinical treating team.

Sponsors

Kirby Institute
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Have voluntarily signed the informed consent form, 2. 18 years of age or older, 3. Injected drugs within the last 6 months, 4. Admitted to hospital with invasive bacterial or fungal infection, a. Examples of invasive infection include: bloodstream infection, bone and joint infection (osteomyelitis, septic arthritis, discitis), central nervous system infection (epidural abscess, meningitis), deep abscess (i.e., brain, liver, muscle, spleen), endovascular infection (infective endocarditis, septic thrombophlebitis, mycotic aneurysm, septic embolism), skin or soft tissue infection (necrotising fasciitis, myositis),

Exclusion criteria

1\) Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Design outcomes

Primary

MeasureTime frameDescription
primary outcome5 yearsTo evaluate the proportion electing for, and factors associated with, patient-directed discharge among PWID admitted for management of invasive IRID.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026