2025-525006-37-00招募中3 期
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Elliniko Institouto Meletis Tis Sipsis10 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 398
- 试验地点
- 10
研究概览
简要总结
The aim of the PROMISE RCT is to demonstrate how early intervention with single dose meropenem in patients with suspicion of infection at risk of death may improve outcome. In PROMISE, early intervention is guided by the presence of only one sign of the qSOFA score or of NEWS2 score equal to 5/6 together with blood PSP ≥300 ng/ml.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Adult (≥ 18 years) patients of both sexes.
- •Suspicion of infection defined as the presence of at least one of: Fever defined as core temperature ≥380 C , Tachycardia defined as more than 90 heart beats/min ,Acute presence of any of: shortness of breath or dysuria, or diarrhea or abdominal pain,Complaints that according to investigator’s discretion indicate/are correlated with the presence of infection
- •Presence of either a) one of qSOFA signs (mental confusion, systolic blood pressure less than 100mmHg, respiratory rate more than 22 breaths/min) OR b) NEWS2 equal to 5 or 6 (see Appendices I and II). It is explicitly stated that patients with 0 qSOFA signs may be enrolled in the study if the NEWS2 is 5 or
- •It is also explicitly stated that patients with NEWS2 less than 5 may be enrolled in the study if qSOFA is equal to one.
- •PSP ≥300ng/ml
排除标准
- •Deny to consent
- •Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.
- •Age less than 18 years
- •Patients with nil signs of qSOFA
- •Patients with two or three qSOFA signs
- •Pregnancy (confirmed by blood or urinary pregnancy test that will be conducted after the signing of the consent form at the emergency department) for female patients of reproductive age or lactation
- •Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors)
- •Hypersensitivity to meropenem, or to any other antibacterial agent that includes meropenem. Severe hypersensitivity to any antibacterial agent belonging to beta lactam class (eg. penicillins or cephalosporins).
- •Patients receiving probenecid, valproic acid or warfarin.
研究组 & 干预措施
Meronem 1g κόνις για ενέσιμο διάλυμα ή διάλυμα προς έγχυση
Test
干预措施: Meronem 1g κόνις για ενέσιμο διάλυμα ή διάλυμα προς έγχυση (Drug)
Sodium Chloride 0,9%
Placebo
干预措施: Sodium Chloride 0,9% (Drug)
结局指标
主要结局
未指定
次要结局
- Duration of hospitalization
研究者
President of the Board
Scientific
Elliniko Institouto Meletis Tis Sipsis
研究点 (10)
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