Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
研究概览
详细说明
Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial), and to conduct a scientifically rigorous international RCT under pandemic circumstances.
Secondary Objectives: To evaluate (i) adherence to the medication administration regimen. (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and withdrawals of consent and (iv) the impact of the approved consent model on recruitment rates.
Study Methods (Overview): Using a web-based randomization system patients, research coordinators will assign critically ill adults treated with antiviral medication for < or equal to 72 hours and requiring mechanical ventilation to one of two treatment strategies (rosuvastatin or placebo) for 14 days. Given the need to recruit patients into the CHAT Trial under pandemic conditions, when family members may not be present to provide written informed consent, we will request either a waiver of consent or deferred consent from Research Ethics Boards (REBs) at participating centres. The Keenan Research Centre/Li Ka Shing Knowledge Institute (St Michael's Hospital, Toronto, Ontario) will be the study Methods Centre.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 1Y6
- St. Paul's Hospital
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Vancouver、British Columbia、加拿大、V5Z 1M9
- Vancouver General Hospital
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Manitoba
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Winnipeg、Manitoba、加拿大、R3B 0Z3
- Health Sciences Centre
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Ontario
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Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Healthcare
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael's Hospital
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Toronto、Ontario、加拿大、M5G 1X5
- Mount Sinai Hospital
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Quebec
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Quebec City、Quebec、加拿大、G1V 4G5
- Hopital Laval
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Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre hospitalier universitaire de Sherbrooke (CHUS)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Critically ill adult patients > or equal to 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed influenza infection
- Requiring mechanical ventilation (invasive or non-invasive)
- Receiving antiviral therapy (any medication at any dose and for any intended duration) for < or equal to 72 hours
- Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for influenza
Exclusion Criteria:
- Age < 16 years
- Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
- Weight < 40 kg
- Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)
Rosuvastatin specific exclusions:
- Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)
- Allergy or intolerance to statins
- Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay
- CK exceeds 10 times ULN or ALT exceeds 8 times the ULN
- Severe chronic liver disease (Child-Pugh Score 11-15)
- Previous enrollment in this trial
- Pregnancy or breast feeding
- At the time of enrollment, patients must not have received >72 hours of antiviral therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Drug (Rosuvastatin) Crestor
The first dose of encapsulated study drug or placebo (day 1) will be administered within 4 hours of randomization as a loading dose of 40 mg.
The placebo will be identical in appearance to Rosuvastatin.
Thereafter, doses of 20 mg will be administered daily starting on the next calendar day at 10 pm daily (+/- 4 hours) as a maintenance dose from days 2 to 14.
If the patient is of Asian descent, is <18 years, or serum creatinine is greater than or equal to 248 μmol/L (2.8 mg/dL) dose adjustments will be made according to a dose adjustment algorithm.
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Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
其他名称：
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安慰剂比较：Placebo
An identical appearing placebo will be administered to patients in the second study arm.
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identical appearing encapsulated placebo.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Proportion of eligible patients enrolled in the CHAT Pilot Trial.
大体时间：anticipated 6 months (duration of pandemic)
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anticipated 6 months (duration of pandemic)
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次要结果测量
结果测量 |
大体时间 |
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Adherence to the medication regimen as outlined in the study protocol.
大体时间：14 day treatment course
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14 day treatment course
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Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial
大体时间：90 days
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90 days
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The number of study withdrawals due to administration of open label statins and consent withdrawals
大体时间：anticipated 6 month study period
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anticipated 6 month study period
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合作者和调查者
合作者
调查人员
- 首席研究员：John C Marshall, MD, FRCPS、Unity Health Toronto
- 首席研究员：Karen EA Burns, MD,FRCPC,MSc、Unity Health Toronto
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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