Protocol for a seamless phase2-3 parallel group randomized controlled trial of corticosteroids in dengue
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Primary outcome related to feasibility consent rate adherence to protocol adverse event profiles
研究概览
简要总结
This will be a seamless phase 2b-3 parallel group multi-centre randomized controlled trial evaluating the effectiveness of intravenous dexamethasone for patients hospitalized with dengue and to evaluate the effectiveness of dexamethasone on days alive and free of organ support at day 28 for patients hospitalized with dengue (phase 3 objective- assumes success of pilot feasibility phas.
Eligible participants are adult (>18yrs) patients admitted to the hospital with dengue (clinical diagnosis as per WHO or respective national criteria or positive for NS1 antigen or dengue polymerase chain reaction) and meeting one of the following criteria:
- Evidence of fluid leak in the form of raised hematocrit or presence of pleural effusion or ascites (detected using bedside ultrasonography)
- Presence of thrombocytopenia (platelet count less than 150000)
- Any evidence of organ dysfunction in the form of altered consciousness, need for O2 supplementation or need for non-invasive or invasive ventilation, vasopressors or kidney replacement therapy
- . Evidence of liver injury (AST or ALT levels 5 times the upper limit of normal)
Primary outcomes related to feasibility (numbers enrolled/month/center), consent rate, adherence to protocol, adverse event profiles etc.,
Secondary outcomes: Days alive and free of hospital until D90, days alive and free or organ support until D28, day 28 and day 90 survival, hospital and ICU length of stay, mean change from baseline in platelet counts at D4 and D7 or hospital discharge whichever is earlier
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible participants are adult (more than18yrs) patients admitted to the hospital with dengue and meeting one of the following criteria
- •Evidence of fluid leak in the form of raised hematocrit or presence of pleural effusion or ascites (detected using bedside ultrasonography)
- •Presence of thrombocytopenia (platelet count less than 150000)
- •Any evidence of organ dysfunction in the form of altered consciousness, need for O2 supplementation or need for non-invasive or invasive ventilation, vasopressors or kidney replacement therapy
- •Evidence of liver injury (AST or ALT levels 5 times the upper limit of normal).
排除标准
- •1.Already on long-term steroid treatment for more than 4 weeks.
- •2.Patients who are expected to die within the next 24 hrs.
- •3.Patients with the presence of an advanced directive for non-initiation of organ support 4.Duration from hospital admission more than 72hrs 5.Active tuberculosis or invasive fungal infection at the time of enrolment.
结局指标
主要结局
Primary outcome related to feasibility consent rate adherence to protocol adverse event profiles
时间窗: Day7 | Day 28 | Day 90
次要结局
- Days alive and free of hospital until D90(Days alive and free or organ support until D28)
研究者
Dr Bharath Kumar
Apollo Hospital ,Chennai