Trials / Not Yet Recruiting
Not Yet RecruitingNCT06220370
PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Kirby Institute · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Invasive Fungal Infections
- Invasive Bacterial Infection
- Injection Site Infection
- Infection, Bacterial
- Infection, Fungal
- Infection, Soft Tissue
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational | There is no clinical intervention as part of this study. Participants will receive treatment as per their clinical treating team. |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2024-01-23
- Last updated
- 2024-02-20
Source: ClinicalTrials.gov record NCT06220370. Inclusion in this directory is not an endorsement.