PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- primary outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
排除标准
- •Is unable or unwilling to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
primary outcome
时间窗: 5 years
To evaluate the proportion electing for, and factors associated with, patient-directed discharge among PWID admitted for management of invasive IRID.
次要结局
未报告次要终点