2025-522215-42-00撤回4 期
Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Days alive and out of hospital at 14 days post-randomization (DAOH-14)
研究概览
简要总结
The primary objective of this trial is to determine if an individualized treatment strategy for patients with severe acute infections can reduce mortality and hospital length of stay.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Suspected acute infection within 72 hours of admission, defined as (1) having samples collected for microbiological evaluation and/or (2) being initiated on antibiotic therapy
- •Admitted to the hospital with an expected duration greater than 24 hours
- •Sequential organ failure assessment (SOFA) ≥2
- •Documented clinical suspicion of infection
排除标准
- •Informed consent following inclusion expected to be unobtainable
- •Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
- •Pregnant or breastfeeding patients
- •Involuntary admission under the Psychiatric Law
- •Admitted to hospital or undergone surgery during the 14 days prior to admission
- •Expected initiation of palliative care within 48 hours of randomization
- •Previous randomization into the current trial
- •Admitted to ICU or expected transfer to ICU within 2 hours
- •Any condition deemed by the investigator to compromise patient safety or trial integrity including, but not limited to: severe coagulopathy, uncontrolled active bleeding, diabetic ketoacidosis
- •Previous severe anaphylaxis
结局指标
主要结局
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
次要结局
- Number of participants with one or more serious adverse event within 14 days of randomization
- Duration of antibiotic therapy within 14 and 30 days of randomization
- Escalation of antibiotic therapy within 14 and 30 days of randomization
- Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization
- Endotracheal intubation for hypoxia within 30 days of randomization
- Initiation of vasoactive medication within 30 days of randomization
- Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization
- Blood transfusion within 30 days of randomization
- Hemoglobin <6.2 within 30 days of randomization
- Days alive and out of hospital at 30 days post-randomization
- All-cause mortality at 14, 30 and 180 days after inclusion
- ICU admission within 14 and 30 days of randomization
- Hospital length of stay within 14 and 30 days of admission
- Health related quality-of-life at 180 days post-randomization (EQ-5D-5L)
研究者
Theis Skovsgaard Itenov
Scientific
Copenhagen University Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate CancerMetastatic Prostate CancerNCT07268794Fudan University112
尚未招募
2 期
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)NCT07266155Longbio Pharma30
招募中
不适用
A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.NCT07263178Boryung Pharmaceutical Co., Ltd1,000
招募中
2 期
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72