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

NCT06220370 | Not Yet Recruiting

• 1 other identifier: PATH
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• primary outcome

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

  5 years

Interventions

Observational OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Have voluntarily signed the informed consent form,
• 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),

You may not qualify if:

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

Sponsors & Collaborators

• Kirby Institute: lead

MeSH Terms

Conditions

Invasive Fungal Infections; Bacterial Infections; Mycoses; Soft Tissue Infections

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share