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

Infection, Bacterial Clinical Trial

— PATH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220370
• Other study ID #: PATH
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2029

Study information

• Verified date: January 2024
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 1, 2029
• Est. primary completion date: March 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infection, Fungal
• Infection, Soft Tissue
• Infections
• Injection Site Infection
• Invasive Fungal Infections
• Mycoses
• Soft Tissue Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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