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NCT Number: NCT06220370

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have voluntarily signed the informed consent form,
  • 18 years of age or older,
  • Injected drugs within the last 6 months,
  • 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

  • Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. primary outcome

    Time frame: 5 years

    To evaluate the proportion electing for, and factors associated with, patient-directed discharge among PWID admitted for management of invasive IRID.

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Acronym: PATH

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 23, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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