Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Proportion of eligible patients enrolled in the CHAT study
研究概览
简要总结
The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.
详细描述
This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill adult patients > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
- •Requiring mechanical ventilation (invasive or non-invasive)
- •Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours
- •Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1
排除标准
- •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) (see Appendix 6)
- •Previous enrolment in this trial
- •Pregnancy or breast feeding
- •At the time of enrolment, patients must not have received >72 hours of antiviral therapy
研究组 & 干预措施
Rosuvastatin
Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug
Both are crushed for administration
干预措施: Rosuvastatin or identical placebo (Drug)
Placebo
Identical drug vehicle with no active agent
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of eligible patients enrolled in the CHAT study
时间窗: Over 6 month period or during H1N1 pandemic
This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic
次要结局
- Adherence to the medication administration regimen as outlined in the study protocol.(2 weeks)
- Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.(6 months)
- The number of study withdrawals due to administration of open label statins and withdrawals of consent.(Up to 28 days or until hospital discharge)
- Recruitment rates by consent model.(6 months)