更新于：2024-05-01

Sepsis

脓毒症

更新于：2024-05-01

基本信息

别名

BLOOD POISONING、Blood Poisoning、Blood Poisonings

+ [76]

简介

Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.

关联

381

项与脓毒症相关的药物

Durlobactam/Sulbactam sodium

舒巴坦钠/度洛巴坦钠

靶点

TEM x β-lactamase

作用机制

TEM抑制剂 [+1]

在研机构

Entasis Therapeutics, Inc. [+3]

原研机构

Entasis Therapeutics, Inc.

在研适应症

医院获得性细菌性肺炎 [+3]

非在研适应症

急性肾盂肾炎 [+3]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-05-23

Vilobelimab

韦洛利单抗

靶点

C5a

作用机制

C5a抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-04-04

Rezafungin acetate

雷扎芬净

靶点

1,3-beta-glucan synthase

作用机制

1,3-β-葡聚糖合酶抑制剂

在研机构

Cidara Therapeutics, Inc. [+4]

原研机构

Cidara Therapeutics, Inc.

在研适应症

念珠菌血症 [+2]

非在研适应症

曲霉菌病 [+3]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-03-22

5,340

项与脓毒症相关的临床试验

NCT06381661 / Not yet recruiting临床3期

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

开始日期2026-04-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

CTRI/2024/01/062078 / Not yet recruiting临床3期

Effect of a nested multiplex polymerase chain reaction (Biofire®) on the duration of empirical antibiotics and risk of treatment failure in asymptomatic neonates with perinatal risk factors for early-onset sepsis - NIL

开始日期2025-09-01

申办/合作机构-

CTRI/2024/03/063630 / Not yet recruitingN/A

Optimizing antimicrobial treatment strategy for Carbapenem resistant Klebsiella pneumoniae bacteremia - NIL

开始日期2025-02-07

申办/合作机构

Indian Council of Medical Research

100 项与脓毒症相关的临床结果

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100 项与脓毒症相关的转化医学

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0 项与脓毒症相关的专利（医药）

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215,939

项与脓毒症相关的文献（医药）

2024-12-31·Human vaccines & immunotherapeutics

"Why has this new vaccine come and for what reasons?" key antecedents and questions for acceptance of a future maternal GBS vaccine: Perspectives of pregnant women, lactating women, and community members in Kenya.

Article

作者: Rupali J Limaye ; Prachi Singh ; Berhaun Fesshaye ; Clarice Lee ; Jessica Schue ; Ruth A Karron

Group B streptococcus (GBS) is a leading global cause of neonatal sepsis and meningitis, stillbirth, and puerperal sepsis. While intrapartum antibiotic prophylaxis (IAP) is a currently available GBS disease prevention strategy, IAP is programmatically complex to implement, precluding use in low- and middle-income countries. In Kenya, 2% of stillbirths are attributable to GBS infection. Two maternal GBS vaccines are in late-stage clinical development. However, licensure of a maternal GBS vaccine does not translate into reduction of disease. We conducted 28 in-depth interviews with pregnant people, lactating people, and community members across two counties in Kenya to better understand the attitudes and informational needs of primary vaccine beneficiaries. We identified two emerging themes from the data. The first focused on antecedents to maternal GBS vaccine acceptability. The most common antecedents focused on the vaccine's ability to protect the baby and/or the mother, followed by community sensitization before the vaccine was available. The second key theme focused on questions that would need to be addressed before someone could accept a maternal GBS vaccine. Three key categories of questions were identified, including vaccine safety compared to vaccine benefits, who gets the vaccine, and how the vaccine works. Realizing the potential benefits of a future GBS maternal vaccine will require a multifactorial approach, including ensuring that communities are aware of GBS-related harms as well as the safety and effectiveness of a maternal GBS vaccine. Our study contributes to informing this multifactorial approach by elucidating the attitudes and concerns of key populations.

2024-12-31·Clinical and experimental hypertension (New York, N.Y. : 1993)

Exploration and validation of signature genes and immune associations in septic cardiomyopathy.

Article

作者: Zhengbo Zhao ; Xiaojing Wang ; Fangyan Tan ; Han Liu ; Wan Chen ; Jing Wang ; Songbai Deng ; Jianlin Du

An early and accurate diagnosis of septic cardiomyopathy is vital for improving the overall prognosis of sepsis. In our research, we aimed to identify signature genes and their immune connections in septic cardiomyopathy. By analyzing the mouse myocardial transcriptome from sepsis induced by cecum ligation and puncture (CLP), we identified four distinct k-means clusters. Further analysis of human myocardial datasets using Weighted Gene Co-expression Network Analysis (WGCNA) revealed a strong correlation between the MEturquoise module and septic cardiomyopathy (cor = 0.79, p < .001). Through the application of Cytoscape plug-in MCODE and comprehensive analysis, we pinpointed two signature genes, THBS1 and TIMP1. These genes demonstrated significant involvement in immune cell infiltration, as detected by CIBERSORT, and displayed promising prognostic potential as validated by external datasets. Our experimental validation confirmed the up-regulation of both THBS1 and TIMP1 in septic murine hearts, underscoring their positive association with septic cardiomyopathy.

2024-12-01·Annals of medicine

Burkholderia cepacia complex in cystic fibrosis: critical gaps in diagnosis and therapy.

Review

作者: Juan Carlos Gutiérrez Santana ; Victor Rafael Coria Jiménez

Burkholderia cepacia complex (Bcc) is a bacterial group with 'natural' multi-antimicrobial resistance. This complex has generated epidemic outbreaks across the world. In people with cystic fibrosis (CF), Bcc can cause severe lung infections that lead to accelerated lung damage, which can be complicated by necrotizing pneumonia accompanied by high fevers, leucocytosis, and bacteraemia, which commonly causes fatal outcomes. Specifically, infection by Burkholderia cenocepacia is considered an exclusion criterion for lung transplantation. The species of Bcc exhibit both genetic and phenotypic hypervariability that complicate their accurate microbiological identification. Automated methods such as MALDI-TOF can err in the determination of species. Their slow growth even in selective agars and the absence of international consensuses on the optimal conditions for their isolation make early diagnosis a difficult challenge to overcome. The absence of correlations between antibiograms and clinical results has resulted in the absence of standardized cut-off values of antimicrobial susceptibility, a fact that brings a latent risk since incorrect antibiotic therapy can induce the selection of more aggressive variants that worsen the clinical picture of the host, added to the absence of a clear therapeutic guide for the eradication of pulmonary infections by Bcc in patients with CF, resulting in frequently ineffective treatments. There is an urgent need to standardize methods and diagnostic tools that would allow an early and accurate diagnosis, as well as to perform clinical studies of the effectiveness of available antibiotics to eradicate Bcc infections, which would allow us to establish standardized therapeutic schemes for Bcc-infected patients.

3,060

项与脓毒症相关的新闻（医药）

2024-04-08

·PRNewswire

Patient Enrolment Completed in CYP-006TK Diabetic Foot Ulcer Clinical Trial

MELBOURNE, Australia, April 7, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: " CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). CYP-006TK is Cynata's Cymerus™ iPSC[1]-derived MSC[2] topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicon dressing. Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if therapy is unsuccessful, amputation may be necessary. In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU. The pre-specified sample size has now been reached, with a total of 30 patients with DFU randomised on a 1:1 basis to receive either: (i) CYP‑006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study. In accordance with the study protocol, patients will be followed for 24 weeks following treatment initiation, which means that the last patient visit in this trial is expected to occur around September 2024. Dr Jolanta Airey MD, Cynata's Chief Medical Officer, said: "We are delighted to have completed enrolment, and we extend our thanks to all of the investigators, study staff and patients for helping us to achieve this milestone. We recently announced very encouraging initial data from the first 16 patients enrolled in this trial after 10 weeks' follow-up, with a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group, compared to 51.1% in the control group. We now look forward to completing the follow-up period and releasing the full results from this study shortly thereafter." -ENDS- Authorised for release by Dr Kilian Kelly, CEO & Managing Director About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. A Phase 2 clinical trial in GvHD under a cleared US FDA IND, as well as trials of Cymerus products in osteoarthritis (Phase 3) and diabetic foot ulcers (DFU) are currently ongoing, while a trial in renal transplant is expected to commence in the near future. In addition, Cynata has also demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group. [1] iPSC = induced pluripotent stem cell [2] MSC = mesenchymal stem (or stromal) cell SOURCE Cynata Therapeutics

临床1期细胞疗法临床结果临床2期临床3期

2024-04-07

·梅斯医学

脓毒症与脓毒性休克：邓跃林教授揭秘临床实战关键策略

脓毒症和脓毒性休克是两个极具挑战性的话题。脓毒症是一种复杂的疾病，其定义为宿主对感染的反应失调，伴有急性器官功能障碍和高死亡风险。脓毒症的发病率很高，目前仍是全球的主要死亡原因之一。你是否在临床工作中遇到过让患者生命垂危的脓毒症和脓毒性休克？是否对这一领域的新诊断标准和处理流程感到困惑？为了帮大家更好地理解和应对这些复杂的临床情况，4月10日19：00，梅斯医学特别邀请到了湘雅医院知名专家——邓跃林教授，直播分享《脓毒症与脓毒性休克：临床实战解析》本次课程重点：1.脓毒症3.0定义的深度解读2.脓毒症的诊断标准与流程3.脓毒性休克的认识与处理4.临床实战案例分享👇扫码报名参与学习👇👇课程学习详情👇点击阅读原文，立即参与学习报名

2024-04-07

·药精通Bio

核酸检测自动化：POCT还是工作站？

TDS2024实验室自动化建设以及在肿瘤、遗传、病原等领域应用论坛；合作热线：17701860390上个月的重庆CACLP，笔者看到越来越多的IVD厂家推出了基于机械臂的大型全自动核酸检测工作站。另一方面，以GeneXpert和FilmArray为代表的分子POCT产品在全球市场中继续一路高歌。那么，谁更能代表核酸检测自动化的未来：分子POCT还是全自动核酸检测工作站？一、与生化、免疫领域不一样的市场表现不可否认的是，在生化检测和免疫诊断领域，与即时检验（POCT）相比，大型的基于机械臂的分析仪在市场中常常扮演着主导地位。这主要是由于这些分析仪具有高精度、高效率和高通量的特点，能够满足大型医疗机构和临床实验室对检测质量、速度和批处理能力的高要求。那在分子诊断领域，是不是也是这样子呢？未来会不会也是大型全自动核酸检测工作站占据着核酸检测的主要市场，而分子POCT只能作为配角出场呢？Frost & Sullivan的市场分析报告显示，2021年全球分子诊断市场规模约为137亿美金。而从公开的数据得知，2021年赛沛旗下的分子POCT产品GeneXpert全年销售额约为35亿美金。此外，2021年Biofire旗下的分子POCT产品FilmArray全年销售额约为13.7亿美元。这两个分子POCT经典产品在2021年销售额之和约占当年全球分子诊断市场的35.5%。单从这个数据来看，分子POCT在新冠疫情期间的2021年怎么也不能算是分子诊断的配角。而样本量极大、检测指标单一的新冠核酸检测，其实恰恰更适合全自动核酸检测工作站。此外，在中国，2021年绝大部分的新冠核酸检测都是依靠传统的核酸检测试剂盒，在PCR实验室里由专业操作人员完成的。所以，我们可以大致推算，2021年全球分子诊断中的137亿美元的市场中，很大一部分仍然是传统的核酸检测试剂盒的市场，然后才是分子POCT，最后留给全自动核酸检测工作站的市场只能说也没多少空间了。公开数据显示，2023年丹纳赫旗下的GeneXpert产品呼吸道感染病原体检测产品线（五条产品线之一）销售额达到了约18亿美元。所以，可以肯定地说，在当前全球分子诊断市场中，分子POCT的实际市场份额应大于全自动核酸检测工作站的市场份额。这又是为什么呢？二、罗氏：我都要我们先看看全球体外诊断老大哥—罗氏在分子诊断中的产品线布局。2015年，罗氏公司旗下的Cobas 6800和8800分子检测系统，以及首个在这些系统上获得批准使用的检测试剂—Cobas HBV和Cobas HCV病毒载量检测均获得了FDA批准。这两款系统是完全集成和自动化的分子检测系统，旨在实现全自动化、增加样本通量和缩短检测时间。这些系统在不到3.5小时内提供最多96个结果，Cobas 6800能在8小时中提供384个结果，Cobas 8800则提供960个结果。两者都可以在同一运行中进行最多三项测试，无需预先分类。此外，这些系统还能够提供长达8小时（Cobas 6800）和4小时（Cobas 8800）的无需用户干预的操作时间。由此可见，罗氏很早就在公司内部布局全自动核酸检测工作站，直到2015年获得FDA医疗器械注册证。另一方面，罗氏也一直密切地跟进全球分子POCT产品的发展，并积极地以并购的形式进入这个领域。2014年，罗氏以4.5亿美元收购了专注于开发分子POCT产品的IQuum公司，从而拥有了分子POCT产品Cobas Liat。但是这次收购并不算成功。新冠疫情期间，本该大卖的Cobas Liat却迟迟没有动静。直到2021年，美国FDA爆出：罗氏诊断Cobas Liat系统对Cobas SARS-CoV-2和A/B流行性感冒核酸测试的出现了假阳性。判断假阳性原因有两点：1. 化验管可能偶尔泄漏并在Cobas Liat分析仪中造成光路阻塞，从而导致PCR生长曲线异常。这可能会导致无效或错误的阳性结果，特别是对于B型流感检测而言。FDA补充道，如果试管确实泄漏，随后的测试可能会增加B型流感假阳性结果的可能。2. 反应管中异常的PCR循环可能产生异常的PCR生长曲线，从而导致假阳性。FDA表示这个问题是零星的，可能是由硬件定位，体积移动和曲线解释引起的。该问题可能对运行中的所有分析物造成误报。2021年，罗氏又以18亿美元的高昂成本收购了GenMark，拥有了分子POCT产品ePlex system。罗氏诊断首席执行官Thomas Schinecker表示：“收购GenMark Diagnostics将扩大我们的分子诊断产品组合，包括能够快速为患者及其医疗保健提供者提供挽救生命的信息的解决方案，以对抗传染病。”所以，从体外诊断老大哥罗氏的分子诊断产品线布局来看：全自动核酸检测工作站很重要，但分子POCT也很重要。这两条产品线，我都要。三、支撑的逻辑传统的核酸检测为什么需要PCR实验室？PCR实验室为什么要分区？为了规避污染，最主要是规避气溶胶污染。阳性样本在PCR反应后期，PCR反应管里的靶基因片段浓度非常高，而PCR反应的变性温度又是九十多度。这样，一旦PCR反应管有漏气，靶基因片段就会随着水蒸气扩增到整个空气中，形成气溶胶污染。整个房间里都弥散着大量靶基因片段。为了规避这个问题，就得需要分区操作，扩增区就得负压。即使我们用机械臂去实现核酸检测的全自动化，我们也得分区：提取和扩增必须在两个物理空间，扩增区必须负压。这样的全自动核酸检测工作站就做不小，也便宜不了。这可不比生化检测和免疫诊断，机械臂的化学发光分析仪可以轻松做成桌面式的，甚至做成单人份的。所有违背PCR实验室分区逻辑的全自动核酸检测工作站都是在耍流氓，使用时间一久，污染就是个确定性事件。全自动核酸检测工作站大一点、贵一点有什么问题呢？毕竟它检测样本通量更大。这就涉及到了检测的时效性和可及性问题了。以GeneXpert和FilmArray最拿手的检测项目—呼吸道感染病原体检测来说，GeneXpert面对的是发热门急诊这个应用场景，而FilmArray面对的是住院部重症肺部感染这个应用场景。这两种应用场景都强调检测的即时性。毕竟，一边大概率是发烧中儿童，另一边大概率是已经确诊为肺炎的儿童或者老人。FilmArray 呼吸道感染检测卡盒已被证明可显著减少ICU入住天数和抗生素使用时间在这类的应用场景中，全自动核酸检测工作站就有点儿为难了。要使用全自动核酸检测工作站，总得攒几个样本吧，不然光是阴、阳性对照也要浪费几人份试剂盒，这还没有考虑其他的开机成本呢。一旦考虑攒样了，时效性就没法保证。其次，对于呼吸道感染而言，哪怕做个门诊初筛，也得多做几个靶标吧？不然的话，阳性检出率也太低了。光是在2023年的中国，乙型流感、合胞病毒、肺炎支原体、副流感病毒都轮番着轰炸，中间还夹杂着鼻病毒、腺病毒等。最后，小点儿的医院买不起也用不起来（样本量不够多）全自动核酸检测工作站吧。感个冒，去个小点儿的医院，发现都没有全自动核酸检测工作站可以用。这个就是可及性的问题。所以，对于呼吸道感染这个应用场景来说，全自动核酸检测工作站检测的时效性不高，又没那么擅长处理多重检测，基本也只能覆盖到三级医院。整个就是没那么适合。但是，不管是GeneXpert还是FilmArray，呼吸道感染都是它们最大的一块检测业务。国内的2023年，圣湘生物的呼吸道产品线也一鸣惊人。但在这个领域，全自动核酸检测工作站主打没那么适合。四、未来的可能未来可能的情况是，在小型医疗机构（一、二级医院），由于检测标本数量有限，不足以支撑全自动核酸检测工作站的样本通量，且这些机构对仪器平台的价格门槛比较敏感，其院内空间也有限，所以分子POCT产品明显更能符合他们的预期。另一方面，对于大医院住院部里的危重症感染（重症肺炎，脓毒血症，脑膜炎等），一方面，为了提高病原体的检出概率，必须要一次筛查尽可能多的病原体，需要的是超多重的检测；另一方面，为了缩短病原体检出的时间，对于TAT时间（检测周转时间）要求非常高。从这两个维度上讲，多重分子POCT平台明显更为适合。此外，对于大医院的门、急诊，为了能快速地解决患者的病痛，医院也为了追求更好的就医体验，都会强调检测出报告的时间。所以，需要攒样本统一上机的全自动核酸检测工作站就没那么合适。反而是针对常见病原体筛查，检测速度快，有一定样本通量的小多重（6-15个指标）分子POCT产品更能体现其产品逻辑上的优势。而全自动核酸检测工作站更适合的是不那么着急出结果，样本量大，而且检测指标相对单一（单指标或者少指标）的检测场景。比较典型的场景就是防疫期间新冠核酸检测，HPV检测，HBV、HCV检测以及血站的血液筛查项目等等。ENDTDS2024实验室自动化建设以及在肿瘤、遗传、病原等领域应用论坛合作热线：17701860390戳“阅读原文”立即领取限量免费参会名额!

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