NCT01145560已完成2 期
A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Ventilator-free Days (VFDs) Over 28 Days
研究概览
简要总结
The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.
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, Investigator)
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
- •Adults with a first episode of sepsis during this hospitalisation and objective evidence of infection that requires parenteral antibiotics.
- •At least 2 of 4 SIRS criteria in the 24 hours before organ dysfunction (must include either fever OR elevated white blood cells [WBC])
- •Cardiovascular or respiratory dysfunction.
排除标准
- •Immunocompromising comorbidities or concomitant medications:
- •Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
- •Stage III or IV cancer.
- •Haemopoietic or lymphoreticular malignancies not in remission.
- •Receiving radiation therapy or chemotherapy.
- •Stem cell, organ or bone marrow transplant in the past 6 months.
- •Absolute neutrophil count <500 per μL.
- •High dose steroids or other immunocompromising drugs.
- •Concomitant diseases:
- •Deep seated fungal infection or active tuberculosis.
- •Cirrhosis with portal hypertension or Childs-Pugh Class C.
- •History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
- •Neuromuscular disorders that impact breathing/spontaneous ventilation.
- •Quadriplegia.
- •Cardiac arrest in the past 30 days.
- •New York Heart Association functional Class IV due to heart failure or any disorder.
- •Burns over > 30% of body surface area.
- •Medication and allergy disqualifications.
- •Treatment with anti-TNF agents within the last 8 weeks.
- •Previously received ovine derived products (CroFab™, DigiFab™).
- •Sheep product allergy or allergy to latex, papain, chymopapain.
研究组 & 干预措施
2
Experimental
AZD9773 500/100 units/kg
干预措施: AZD9773 (Drug)
1
Experimental
AZD9773 250/50 units/kg
干预措施: AZD9773 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Ventilator-free Days (VFDs) Over 28 Days
时间窗: Over 28 days following first dose
Number of ventilator-free days (VFDs)
次要结局
- 7-day Mortality(Over 7 days following first dose)
- 28-day Mortality(Over 28 days following first dose)
- Safety and Tolerability(All study visits (over 90 days following first dose))
研究者
研究点 (1)
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