NCT00604214已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,696
- 试验地点
- 1
- 主要终点
- 28-Day All-Cause Mortality
研究概览
简要总结
The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.
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
- Double (Participant, 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
- •Must be 18 years or older
- •Must have evidence of infection
- •Must have systemic inflammatory response syndrome (SIRS)
- •Must have vasopressor-dependent septic shock
排除标准
- •Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
- •Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
- •Have single organ dysfunction and recent surgery (within 30 days of study entry)
- •Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
- •Are not expected to survive 28 days given their preexisting uncorrectable medical condition
研究组 & 干预措施
Drotrecogin alfa (activated)
Experimental
干预措施: Drotrecogin alfa (activated) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
28-Day All-Cause Mortality
时间窗: Day 28
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
次要结局
- Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28(Day 1 through Day 28)
- 180-Day Mortality(Day 180)
- Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180(Baseline and Days 28 and 90 and 180)
- 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency(Day 28)
- Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28(Day 1 through Day 28)
- Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28(Day 1 through Day 28)
- 90-Day Mortality(Day 90)
- Median Survival Time(Day 180)
- EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180(Baseline and Days 28 and 90 and 180)
- EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180(Baseline and Days 28 and 90 and 180)
- Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint(Baseline through Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial VaginosisHUDC_VTHaudongchunBacterial VaginosisNCT03357666Haudongchun Co., Ltd.150
已完成
1 期
A Study of CDX-0159 in Patients With Prurigo NodularisPrurigo NodularisNCT04944862Celldex Therapeutics24
已完成
2 期
Study of Leptin for the Treatment of Hypothalamic AmenorrheaAmenorrheaNCT00130117Beth Israel Deaconess Medical Center20
已完成
2 期
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationSmoking CessationNCT00139750Pfizer600
Unknown
2 期
A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in FemalesIrritable Bowel SyndromeNCT00547469Dynogen Pharmaceuticals360