Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events of intravenous zanamivir treatment versus placebo in dengue
研究概览
简要总结
ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever.
详细描述
ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever. Our central hypothesis is that zanamivir treatment is safe in patients with dengue infection, will significantly decrease serum sialic acid levels, and will result in fewer patients with the development of moderate or severe clinical plasma leakage. 74 male and non-pregnant female volunteers age 7 years and older from Colombia with a diagnosis of dengue fever with warning signs or severe dengue as per the World Health Organization 2009 definition with the presence of fever and positive rapid test for the presence of dengue non-structural protein-1 (NS1) will be randomized to zanamivir versus placebo. In the treatment group, all participants weighing less than 50 kg will receive 12 mg/kg and all participants weighing 50 kg and above will receive 600 mg as the initial dose intravenously every twelve hours for 5 days adjusted for renal function. In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
All patients will receive blood draws for assessment of hematocrit, renal function, and biologic efficacy endpoints and clinical evaluation of signs and symptoms of vascular permeability (which may include ultrasound and radiograph) and adverse events daily during the five days of medication administration and once at follow up at 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged >7 years
- •Willingness to receive intravenous medication and be willing to adhere to the medication regimen
- •Have a diagnosis of dengue by dengue NS1 rapid test
- •Have had a self-informed fever >38 degrees C in the last 3 days.
- •Have dengue with warning signs as per the 2009 WHO criteria including one of the following: abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy, restlessness, liver enlargement over 2 cm, augmented hematocrit, thrombocytopenia or severe dengue defined as dengue with severe plasma leakage leading to dengue shock and/or fluid accumulation with respiratory distress; severe hemorrhage; severe organ impairment (hepatic damage, renal impairment, cardiomyopathy, encephalopathy or encephalitis).
- •Enrollment in EPS (Entidadas Promotoras de Salud) or Sistema General de Seguridad Social en Salud (SGSSS)- Colombian Public Health Insurance.
排除标准
- •Pregnancy or lactation
- •Children in Care of the state
- •Patients who are unlikely to survive 48 hours
- •Unstable cardiac disease or arrhythmia at baseline
- •History of significant cardiac disease
- •Treatment with another investigational drug or other intervention within 1 month.
- •Encephalitis or unable to consent
研究组 & 干预措施
Zanamivir
In the treatment group, participants weighing less than 50 kg will receive 12 mg/kg and those weighing 50 kg and above will receive 600 mg as the initial dose intravenously every twelve hours for 5 days adjusted for renal function.
干预措施: Zanamivir (Drug)
Placebo
In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events of intravenous zanamivir treatment versus placebo in dengue
时间窗: Over 14 days
Incidence of Treatment-Emergent Adverse Events will be assessed by daily active surveillance during drug administration and at 2-week follow-up as per the United States Food and Drug Administration guidelines.
次要结局
- Levels of endothelial glycocalyx biomarkers in intravenous zanamivir treatment versus placebo in dengue(Over 14 days)
- Preliminary clinical efficacy of intravenous zanamivir treatment versus placebo in dengue(Over 14 days)
研究者
Aileen Y Chang
PI
George Washington University