Integrating the Diagnosis and Management of HIV-associated Central Nervous System (CNS) Infections Into Routine Health Services in Low and Middle Income Countries (LMICs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 5
- 主要终点
- 2-week all-cause mortality
研究概览
简要总结
The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment algorithm and, 4) Communities of practice in infectious diseases and laboratory capacity building) when combined reduce two week all-cause mortality of HIV-associated meningo-encephalitis in African LMICs.
详细描述
HIV-associated central nervous system (CNS) infection causes significant mortality and places a high burden on limited health care resources in Sub-Saharan Africa (SSA). Cohort and autopsy studies estimate that CNS infections cause up to a third of HIV-related deaths in African LMICs.
Cryptococcal meningitis alone is estimated to account for up to 20% of HIV-related mortality and its' incidence in Africa, unlike in resource-rich settings, has remained high despite antiretroviral roll out.
In African low and middle-income countries (LMICs) mortality associated with cryptococcal meningitis has been estimated at 70% at 3 months.
Tuberculous meningitis mortality also remains unacceptably high and is reported at over 70% in a study from Cameroon. Delays in diagnosis are key causes of poor patient outcomes for tuberculous and bacterial meningitis, and cryptococcal meningitis where patients present late and with advanced disease.
The aim of the DREAMM study is to drive down this unacceptably high mortality associated with HIV-associated meningo-encephalitis in LMICs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Consecutive patients > 18 years with 1st episode of suspected meningo- encephalitis
- •Known to be HIV positive or willing to undertake an HIV test
- •Willing to agree to participate in the study
排除标准
- •Patients presenting with suspected relapse of HIV-associated meningo-encephalitis
- •HIV negative patients
- •Pregnant or lactating patients
- •Patients presenting with a known diagnosis of primary CNS Lymphoma or cerebral malaria
- •COVID-19 infected patients
- •Patients who are HIV negative or are diagnosed with cerebral malaria on hospital admission or after initial investigation will be excluded or withdrawn from the DREAMM study.
结局指标
主要结局
2-week all-cause mortality
时间窗: 2 weeks from enrolment
2-week all-cause mortality from enrolment
次要结局
- Time to appropriate, microbiologically guided treatment(10 weeks from enrolment)
- 4-week all-cause mortality(4 weeks from enrolment)
- 10-week and 6-month rate of death(10 weeks and 6 months from enrolment)
- 6-month all-cause mortality(6 months from enrolment)
- 10-week all-cause mortality(10 weeks from enrolment)
- Time to appropriate investigation: lumbar puncture, brain imaging(10 weeks from enrolment)
- Prevalence of cryptococcal, tuberculous and bacterial meningitis and toxoplasma meningo-encephalitis and neurosyphilis(10 weeks from enrolment)
- Time to ART initiation(10 weeks from enrolment)