Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): a Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial

Previous observational studies have identified Acinetobacter baumannii (AB), Pseudomonas aeruginosa (PA), and Klebsiella pneumoniae (KP) as the predominant pathogens responsible for ventilator-associated pneumonia (VAP). The challenge of drug resistance is intensifying, with variations noted across different regions. Recent findings from a multicentre randomized controlled trial suggest that the prophylactic use of inhaled antibiotics may reduce the risk of VAP in critically ill patients. Colistin methanesulfonate sodium (CMS) has shown effectiveness against gram-negative bacteria, including carbapenem-resistant organisms such as carbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant Klebsiella pneumoniae (CRKP). This trial aims to evaluate the efficacy of a 3-day course of inhaled CMS in lowering the incidence of VAP among patients undergoing invasive mechanical ventilation for at least 3 days.

开始日期2025-02-01

申办/合作机构

山东大学齐鲁医院

CTRI/2024/12/077762

/ Not yet recruitingN/A

A prospective, non-randomized Population Pharmacokinetic study of Colistin in critically ill patients - NIL

开始日期2024-12-25

申办/合作机构

Post Graduate Institute of Medical Education & Research

NCT06702943

/ Not yet recruitingN/AIIT

Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections

This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.
Inclusion Criteria:
Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.
EVD placement for managing CNS infections.
Exclusion Criteria:
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Neonates (less than 1 month old), pregnant, or breastfeeding patients.
Outcome Measures:
Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).
Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.

开始日期2024-12-01

申办/合作机构

Ain Shams University

100 项与多黏菌素E甲磺酸钠相关的临床结果

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100 项与多黏菌素E甲磺酸钠相关的转化医学

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100 项与多黏菌素E甲磺酸钠相关的专利（医药）

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项与多黏菌素E甲磺酸钠相关的文献（医药）

2025-12-01·CURRENT GENETICS

Metagenomic surveillance of microbial community and antibiotic resistant genes associated with Malaysian wastewater during the COVID-19 pandemic

Article

作者: Hooi, Suet Li ; Shahid, Umama ; Mohd Aris, Alijah ; Tan, Hock Siew ; Khor, Bee Chin ; Lim, Shu Yong ; Ayub, Qasim

Wastewater is a reservoir of pathogens and hotspots for disseminating antibiotic resistance genes across species. The metagenomic surveillance of wastewater provides insight into the native microbial community, antibiotic-resistance genes (ARGs) and mobile genetic elements. t. The COVID-19 pandemic has caused wider dissemination of ARGs and resistant bacteria in wastewater. Although immensely significant, no research has been performed on the Malaysian wastewater microbial community and ARGs or their correlation with COVID-19 infections. This study utilised a 16S metagenomics approach to characterise the microbial community in Malaysian wastewater during high and low-case phases of the pandemic. Bacteria belonging to Bacteriodales, Bacillales, Actinomycetales and opportunistic pathogens-Arcobacters, Flavobacteria, and Campylobacterales, Neisseriales, were enriched during higher COVID-19 pandemic (active cases). Additionally, copy number profiling of ARGs in water samples showed the prevalence of elements conferring resistance to antibiotics like sulphonamides, cephalosporins, and colistin. The high prevalence of intI1 and other ion-based transporters in samples highlights an extensive risk of horizontal gene transfer to previously susceptible species. Our study emphasises the importance of wastewater surveillance in understanding microbial community dynamics and ARG dissemination, particularly during public health crises like the COVID-19 pandemic.

2025-12-01·MOLECULAR BIOLOGY REPORTS

Green synthesis of silver nanoparticles using Acroptilon repens aqueous extract and their antibacterial efficacy against multidrug-resistant Acinetobacter baumannii

Article

作者: Shamsoddini, Seyed Mahdi ; Shahbazi, Shahla ; Karizi, Shohreh Zare ; Davoudi, Mahdieh

BACKGROUND:

Acinetobacter baumannii is a critical pathogen associated with hospital-acquired infections, particularly in burn and intensive care unit (ICU) patients, and is notorious for its high level of antibiotic resistance. This study aims to evaluate the antibacterial potential of silver nanoparticles (AgNPs) synthesized using Acroptilon repens extract as a promising alternative treatment for combating multidrug-resistant A. baumannii.

METHODS AND RESULTS:

Twelve clinical isolates of A. baumannii were identified through biochemical testing. Antibiotic susceptibility testing using the Kirby-Bauer disk diffusion method revealed universal resistance to ceftazidime, amikacin, imipenem, gentamicin, ciprofloxacin, and piperacillin-tazobactam, while all isolates remained sensitive to colistin (p ≤ 0.05). AgNPs were synthesized using A. repens extract and characterized through transmission electron microscopy (TEM), scanning electron microscopy (SEM), particle size analysis (PSA), UV-Vis spectroscopy, X-ray diffraction (XRD), and Fourier-transform infrared spectroscopy (FT-IR). TEM analysis showed that the AgNPs had a spherical morphology with an average particle size of approximately 30 nm, while SEM confirmed their spherical shape and size distribution, ranging from 10 to 130 nm, with a mean size of 38.89 nm. UV-Vis spectroscopy confirmed the successful formation of AgNPs, indicated by a distinct broad absorption peak between 400 and 480 nm. XRD analysis validated the crystalline nature of the nanoparticles, with characteristic peaks at 2θ values of 38.21°, 46.28°, 64.57°, and 77.49°, corresponding to the (111), (200), (220), and (311) planes of face-centered cubic (fcc) silver. Antibacterial activity was evaluated by determining the minimum inhibitory concentration (MIC), which ranged from 50 to 400 µg/mL. The highest inhibitory activity was observed at 400 µg/mL. Gene expression analysis using quantitative real-time PCR (qRT-PCR) demonstrated downregulation of the oprD and carO porin genes following AgNP treatment. However, these reductions were not statistically significant (p = 0.302 and p = 0.198, respectively).

CONCLUSIONS:

AgNPs synthesized from A. repens demonstrated strong antibacterial activity against multidrug-resistant A. baumannii. While downregulation of porin genes was observed, further investigation is required to elucidate the underlying mechanisms of action and assess their potential clinical applications. These findings support the potential of AgNPs as an alternative therapeutic strategy for addressing A. baumannii infections resistant to conventional antibiotics.

2025-06-01·MICROBIOLOGICAL RESEARCH

Lactobacilli-derived extracellular vesicles as synergistic biomolecules for colistin efficacy against Acinetobacter baumannii

Article

作者: Kim, Jisung ; Kim, Kwang-Sun ; Cho, Hyejin

Acinetobacter baumannii (A. baumannii), a gram-negative bacterium resistant to antibiotics, presents substantial medical challenges, causing nosocomial infections with high fatality rates. Colistin (COL) is frequently employed as a last-line defense against these pathogens. Nevertheless, its therapeutic efficacy has been significantly reduced due to the emergence of COL-resistant strains. With the slow development of novel antibiotics, researchers have explored materials to boost the effectiveness of COL against such pathogens. Postbiotics, comprising bioactive compounds derived from probiotic microorganisms, have shown potential antibacterial properties and may work synergistically with certain antibiotics. This study aimed to confirm the role of extracellular vesicles (EVs) as a collection of bioactive molecules that could potentially synergize with COL. EVs from various Lactobacilli strains (LEVs) were evaluated for their effect on COL susceptibility. The findings indicated that, compared to COL treatment alone, LEVs enhanced 4- to 8-fold bactericidal efficacy of COL against A. baumannii strains in the level of minimum inhibitory concentrations (MIC). Additional mechanistic investigations into the synergistic effects of LEVs on established COL mechanisms, including lipopolysaccharide binding, reactive oxygen species (ROS) generation, and biofilm formation, showed that LEVs act as either ROS enhancers or biofilm inhibitors, depending on the bacterial strains. Finally, we demonstrated that repeated use of LEVs did not induce COL resistance in A. baumannii. These results provide the first evidence that LEVs can serve as effective postbiotics, enhancing the susceptibility of A. baumannii strains to COL.

项与多黏菌素E甲磺酸钠相关的新闻（医药）

2025-03-03

·正大天晴药业集团

月度盘点 | 正大天晴2月要闻回顾

过去的一个月正大天晴发生了哪些新鲜事让我们一起来回顾一下吧 #1 国产首创突破！妥洛特罗贴剂（德瑞妥）获批上市，守护全年龄段呼吸疾病患者健康 2月7日，北京泰德制药研发的妥洛特罗贴剂（商标名：德瑞妥）获得国家药品监督管理局颁发的上市批件，是首个获批上市的国产妥洛特罗贴剂。这款创新贴剂，通过透皮给药系统实现药剂缓释，即可在“晨降”高危时段持续舒张支气管，降低夜间发病风险。正大天晴将携手北京泰德制药保证该产品供应，守护全年龄段呼吸疾病患者健康。（点击此处跳转至原链接） #2 正大天晴国内率先完成等效性研究，乌美溴铵维兰特罗吸入粉雾剂上市申请获受理 2月9日，正大天晴开发的乌美溴铵维兰特罗吸入粉雾剂上市申请获CDE受理，适用于慢性阻塞性肺疾病（COPD）的长期维持治疗，有望为国内超1亿慢阻肺病患者提供新的治疗选择。正大天晴作为国内首家完成双支扩粉雾剂等效性研究的医药企业，此次申报进程的推进将进一步巩固公司在呼吸系统疾病治疗领域的领先地位。（点击此处跳转至原链接） #3 彭博《商业周刊》专访谢其润：只有创新才能在全球医药竞争中立足中国生物制药董事会主席谢其润获选“2024彭博《商业周刊》年度人物50”。2月14日，《商业周刊》发表了题为《中国生物制药董事会主席谢其润：只有创新才能在全球医药竞争中立足》的专访文章。（点击此处跳转至原链接） #4 纳入国家优化创新药临床试验审评试点项目，正大天晴1类新药研发提速 2月11日，正大天晴申报的1类创新药TQB2210临床试验申请获国家药监局药品审评中心（CDE）受理。作为公司首个纳入《优化创新药临床试验审评审批试点工作方案》的试点项目，TQB2210临床试验审评周期将缩短50%以上，从而有望更快惠及肿瘤患者。近年来，企业通过研发投入与政策借力，实现创新药管线的爆发式增长。（点击此处跳转至原链接） #5 安罗替尼“再挑战”研究入选2025 ESMO SRCC小型口头报告盐酸安罗替尼关于晚期软组织肉瘤（STS）的多中心回顾性研究，入选2025年欧洲肿瘤内科学会肉瘤及罕见肿瘤大会（ESMO SRCC）小型口头报告（Mini Oral）。该研究聚焦于安罗替尼“再挑战”既往治疗发生进展STS患者的疗效与安全性，将于3月20日至22日在瑞士卢加诺举行的大会上展示最新研究数据。（点击此处跳转至原链接） #6 南京市委书记周红波会见谢承润：支持打造百亿级链主企业共建生物医药创新发展高地 2月19日，南京市委书记周红波会见中国生物制药首席执行长、正大天晴董事长谢承润一行。（点击此处跳转至原链接） #7 《新华日报》头版头条文章点赞正大天晴 2月20日，《新华日报》头版头条发表文章《其命维新，稳步走好“第一方阵”》，对2024年江苏因地制宜发展新质生产力，“创新江苏”多项指标全国居首，进行了深度报道。其中，正大天晴聚焦国际前沿靶点，在肿瘤、肝病、呼吸等重点治疗领域创新药物研发成果斐然受到关注。（点击此处跳转至原链接） #8 当选上海生物医药商会副会长谢承润:以“创新”“国际化”为战略双翼构建全球化产业协同体系 2月22日，上海市工商联生物医药商会第一届一次会员会议暨生物医药发展大会举行。上海市副市长刘多、陈宇剑，市政协副主席、市工商联主席寿子琪，中国药学会理事长孙咸泽出席。当选副会长的中国生物制药首席执行长、正大天晴董事长谢承润受邀参加“创新与出海”圆桌会，表示将以“数字化赋能”与“生态链协同”推动创新突破与国际化布局，与行业伙伴携手推动中国医药从“跟随”到“引领”的跨越。（点击此处跳转至原链接） #9 正大天晴“靶免联合”新突破，肺巨细胞癌患者无进展生存期达30个月 1类创新药安罗替尼联合派安普利单抗治疗晚期肺巨细胞癌的罕见病例报道，在医学期刊《Frontiers in Oncology》上发表，成功帮助一名晚期肺巨细胞癌伴脑转移、PD-L1高表达和TP53突变患者实现无进展生存30个月，为罕见肺癌治疗提供了新的思路和希望。（点击此处跳转至原链接） #10 “天韵”破局！新研究为血液病合并脓毒症治疗提供关键证据当地时间2月23日至25日，一项关于多黏菌素E甲磺酸钠（商标名：天韵）治疗血液病合并脓毒症的研究在美国重症医学会年会（SCCM 2025）以口头报告的形式公布，为破解这一困局提供了关键证据。（点击此处跳转至原链接） #11 关注罕见病，让生命不因“罕见”而孤独全球3.5亿罕见病患者中，中国有近2000万患者在与命运抗争。正大天晴2款在研的重磅产品正致力于攻克《罕见病目录》中的治疗难题。《罕见病目录》之外，正大天晴还有4款1类新药，正在向发病率极低的国际罕见病种发起挑战。（点击此处跳转至原链接）注：以上内容根据本公众号发稿时间统计。声明：本文的著作权由原作者或本公司享有，未经授权，不得以转载、复制、摄制、改编、汇编等方式使用。文中出现的人物肖像，其肖像权归本人所有，未经授权，禁止使用。 ● 月度盘点 | 正大天晴12月要闻回顾 ● 月度盘点 | 正大天晴11月要闻回顾 ● 月度盘点 | 正大天晴10月要闻回顾

上市批准申请上市

2025-02-26

·正大天晴药业集团

“天韵”破局！新研究为血液病合并脓毒症治疗提供关键证据

有研究表明，近三成血液病患者在治疗的第一年里因严重感染而发生脓毒症[1]，其中碳青霉烯类耐药病原菌（CRO）感染所致的脓毒症病死率高、危害大，成为临床医生面临的重大挑战[2]。当地时间2月23日至25日，一项关于多黏菌素E甲磺酸钠（商标名：天韵）治疗血液病合并脓毒症的研究在美国重症医学会年会（SCCM 2025）以口头报告的形式公布，为破解这一困局提供了关键证据。该研究回顾性分析了多黏菌素E甲磺酸钠在真实世界中治疗中国血液病合并脓毒症患者的有效性和安全性，旨在为多黏菌素E甲磺酸钠的临床应用提供更多证据，实现血液病患者脓毒症的精准治疗。研究聚焦81例确诊脓毒症的血液病患者，其中白血病患者占66.67%，其次为淋巴瘤、再生障碍性贫血，32.1%的患者曾接受异基因造血干细胞移植，72.84%的患者在感染开始时发生中性粒细胞减少。研究结果表明，在采用多黏菌素E甲磺酸钠治疗后，患者的临床有效率为62.96%，微生物清除率为59.26%，ICU和总住院时间的中位数分别为13.5天和33天[3]。值得注意的是，血液病患者通常有严重的基础疾病并伴有其他肾毒性药物治疗，因此关注多黏菌素E甲磺酸钠肾毒性尤为重要。此次研究中，纳入的患者均被诊断为脓毒症，使用多黏菌素E甲磺酸钠后感染得到控制，18.5%的患者出现肾功能不全的不良反应，无永久性肾功能丧失病例发生[3]。多黏菌素E甲磺酸钠（商标名：天韵）由正大天晴开发，于2021年10月获批上市，斩获国内首仿。血液病患者作为多重耐药细菌尤其是碳青霉烯类耐药革兰阴性菌感染的高危群体，其脓毒症病死率居高不下，含多黏菌素E甲磺酸钠的联合抗感染治疗方案为此类患者的临床救治提供了新的参考。参考文献： [1] MacPhail A, Dendle C, Slavin M, Weinkove R, Bailey M, Pilcher D, et al. Sepsis mortality among patients with haematological malignancy admitted to intensive care 2000-2022: a binational cohort study. Crit Care. 2024;28(1):148. [2] Hansen BA, et al. Febrile Neutropenia in Acute Leukemia. Epidemiology, Etiology, Pathophysiology and Treatment. Mediterr J Hematol Infect Dis. 2020;12(1):e2020009. [3] Xie Yan, Fu jianhong, et al. COLISTIN IS EFFICACIOUS AND SAFE FOR THEMANAGEMENT OF SEPSIS IN HEMATOLOGICAL DISEASESPATIENTS. Critical care Medicine 53(1): january 2025. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 当选上海生物医药商会副会长谢承润:以“创新”“国际化”为战略双翼构建全球化产业协同体系 ● 南京市委书记周红波会见谢承润：支持打造百亿级链主企业共建生物医药创新发展高地 ● 彭博《商业周刊》专访谢其润：只有创新才能在全球医药竞争中立足 ● 正大天晴“靶免联合”新突破，肺巨细胞癌患者无进展生存期达30个月

临床研究上市批准微生物疗法

2025-02-18

·正大天晴

就在本周！广谱抗生素新成果将在美国重症医学会年会口头汇报

当地时间2月23日至25日，第54届美国重症医学会年会（2025 SCCM）将在奥兰多举行。中国生物制药（1177.HK）下属企业正大天晴将以口头报告的形式，公布多黏菌素E甲磺酸钠治疗血液病伴脓毒症的最新研究成果，让中国方案惠及全球患者。耐药革兰阴性菌感染是血液病患者入住重症监护室（ICU）和死亡的主要原因，多黏菌素作为治疗这类患者的“最后一道防线”，被视作临床上不可替代的核心药物[1,2]。耐药革兰阴性菌感染正迅速演变为全球公共卫生领域的重大威胁，特别是多次化疗或造血干细胞移植后粒细胞缺乏患者容易合并多重耐药菌感染。由于其多重耐药性，临床治疗选择有限，致使患者病死率居高不下。多黏菌素E甲磺酸钠作为治疗多重耐药铜绿假单胞菌、鲍曼不动杆菌等革兰阴性菌的“最后防线”，因其耐药率低于5%且无交叉耐药性，成为重症感染救治的核心药物[3,4]。正大天晴于2021年10月国内首仿获批多黏菌素E甲磺酸钠（商标名：天韵），填补了这类药物的国产空白。由于多黏菌素E甲磺酸钠在我国上市较晚，目前基于中国人群的循证证据有限，尤其是在血液病患者脓毒症的治疗方面还缺乏有说服力的研究成果。此次将在SCCM年会展示的研究成果，回顾性分析了多黏菌素E甲磺酸钠在真实世界中治疗中国血液病合并脓毒症患者的有效性和安全性，旨在为该类抗生素的临床应用提供更多证据，实现血液病患者脓毒症的精准治疗。参考文献： [1] ARDEBILI A,IZANLOO A,RASTEGAR M.Polymyxin combination therapy for multidrug-resistant,extensively-drug resistant,and dificult-to-treat drug-resistant Gram-negative infections:is it superior to polymyxin mono-therapy?[J].Expert Rev Anti Infect Ther,2023,21(4):387-429. [2] Azoulay E, Mokart D, Pène F, Lambert J, Kouatchet A, Mayaux J, et al. Outcomes of critically ill patients with hematologic malignancies: prospective multicenter data from France and Belgium--a groupe de recherche respiratoire en réanimation onco-hématologique study.J Clin Oncol.2013;31(22):2810-2818. [3] Tsuji BT et al. International Consensus Guidelines for the Optimal Use of the Polymyxins:Endorsed by the American College of Clinical Pharmacy(ACCP), European Society of Clinical Microbiology and Infectious Diseases(ESCMID), Infectious Diseases Society of America(IDSA), International Society for Antiinfective Pharmacology(ISAP), Society of Critical Care Medicine(SCCM), and Society of Infectious Diseases Pharmacists(SIDP).Pharmacotherapy.2019 Jan;39(1):10-39. [4] 胡付品,等.CHINET 2024年上半年细菌耐药监测结果. 声明： 1. 本新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。 2. 本公司不对任何药品和/或适应症作推荐。 3. 本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。前瞻性声明：本新闻稿中包含若干前瞻性陈述，包括有关【多黏菌素E甲磺酸钠（商标名：天韵）】的临床开发计划、临床获益与优势的预期、商业化展望、患者临床获益可能性，以及潜在商业机会等声明。“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“有望”、“打算”、“计划”、“潜在”、“预测”、“预计”、“应该”、“将”、“拟”、“会”和类似表达旨在识别前瞻性陈述，但并非所有前瞻性陈述都包含这些识别词。这些前瞻性陈述为公司基于当前所掌握的数据和信息所做的预测或期望，可能因受到政策、研发、市场及监管等不确定因素或风险的影响，而导致实际结果与前瞻性陈述有重大差异。请现有或潜在的投资者审慎考虑可能存在的风险，并不可完全依赖本新闻稿中的前瞻性陈述，该等陈述包含信息仅及于本新闻稿发布当日。除非法律要求，本公司无义务因新信息、未来事件或其他情况而对本新闻稿中任何前瞻性陈述进行更新或修改。

临床研究

100 项与多黏菌素E甲磺酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02049	多黏菌素E甲磺酸钠	J01XB01 A07AA10	DB01111

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
革兰氏阴性菌感染	中国	正大天晴药业集团股份有限公司	2021-10-11
肺部感染	欧盟	Essential Pharma Ltd.	2012-02-13
肺部感染	冰岛	Essential Pharma Ltd.	2012-02-13
肺部感染	列支敦士登	Essential Pharma Ltd.	2012-02-13
肺部感染	挪威	Essential Pharma Ltd.	2012-02-13
囊性纤维化	澳大利亚	Phebra Pty Ltd.	2011-02-02
铜绿假单胞菌感染	澳大利亚	Phebra Pty Ltd.	2011-02-02
感染	美国	Endo Operations Ltd.	1970-06-04
感染性肠炎	日本	Sun Pharma Japan Ltd.	1960-11-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
耐碳青霉烯类细菌感染	临床3期	中国	正大天晴药业集团股份有限公司	2023-07-06
慢性肺疾病	临床3期	美国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	阿根廷	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	澳大利亚	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	加拿大	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	法国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	德国	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	希腊	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	以色列	Zambon SpA	2018-01-29
慢性肺疾病	临床3期	意大利	Zambon SpA	2018-01-29

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03460704 (PROMIS-II, CTgov)	临床3期	非囊性支气管扩张 \| 慢性肺疾病	287	CMS (CMS (Colistimethate Sodium))	構鹹蓋製壓遞襯壓製觸(網糧壓醖艱齋鏇衊鑰壓) = 製顧餘願餘窪艱築襯蓋衊淵鏇襯繭積膚獵範膚 (艱繭構齋壓醖網鏇餘夢, 鬱膚衊蓋襯蓋襯壓齋願 ~ 廠齋鬱製遞窪積餘艱網)	-	2023-12-29
				Placebo (Placebo)	構鹹蓋製壓遞襯壓製觸(網糧壓醖艱齋鏇衊鑰壓) = 繭鑰鹹顧憲艱鑰簾餘網衊淵鏇襯繭積膚獵範膚 (艱繭構齋壓醖網鏇餘夢, 蓋願觸衊獵積夢齋鏇觸 ~ 積網網顧鏇憲積遞膚鹽)
NCT03093974 (PROMIS-I, CTgov)	临床3期	非囊性支气管扩张 \| 感染	377	Placebo	糧網遞憲餘壓製鬱鏇鹽(選鑰構積鏇鹹齋鬱醖廠) = 願願廠範壓網顧顧構膚願範艱夢獵糧簾範製簾 (遞壓範廠鹹顧鏇壓鏇鑰, 遞夢齋廠糧鑰蓋鹹鑰齋 ~ 鹽網淵鏇鑰顧範蓋鏇鑰)	-	2023-11-15
NCT03093974 (PROMIS-I, Corporate Publications) 人工标引	临床3期	非囊性支气管扩张	377	Colistimethate Sodium	夢構願遞鑰廠鬱選襯艱(憲獵簾膚鏇選製窪夢顧) = 獵餘顧齋窪築夢夢壓齋鏇鏇淵範積膚構艱衊夢 (蓋遞衊醖構願壓鹹醖鹹 )	积极	2021-09-08
				Placebo	夢構願遞鑰廠鬱選襯艱(憲獵簾膚鏇選製窪夢顧) = 糧遞網糧願願積蓋蓋繭鏇鏇淵範積膚構艱衊夢 (蓋遞衊醖構願壓鹹醖鹹 )
NCT03093974 (PROMIS-I, ERS2021)	临床3期	支气管扩张 Pseudomonas aeruginosa	377	Colistimethate sodium I-neb	鏇餘憲醖糧觸選鹽鑰壓(夢壓鏇鹽選醖憲繭膚網) = 艱齋選築鏇艱遞窪顧繭鹽餘鹹繭襯醖積窪網艱 (廠糧網觸糧淵積蓋壓淵 )	积极	2021-09-05
				Placebo	鏇餘憲醖糧觸選鹽鑰壓(夢壓鏇鹽選醖憲繭膚網) = 構餘構廠簾鏇壓遞淵觸鹽餘鹹繭襯醖積窪網艱 (廠糧網觸糧淵積蓋壓淵 )
OPEN STUDY OF THE ASSOCIATIONCOLIMYCINE / GENTAMYCIN (UEGW2019)	N/A	盲袢综合征	99	COLIGENTA (COLIMYCINE / GENTAMYCINE)	衊鹽廠糧鹽願網觸觸願(糧觸夢願醖鑰鏇鹽積鬱) = 築觸鏇獵蓋糧繭蓋廠觸鏇遞築繭製夢鏇艱獵窪 (獵鏇淵膚淵餘選繭製願 ) 更多	积极	2019-10-01
ASN2017	N/A	急性肾损伤	126	Colistimethate Sodium	窪構構鑰顧壓選製夢鹽(襯遞壓鏇構壓願膚鬱築) = 膚廠顧壓夢鹹範蓋鬱憲窪網膚艱襯觸簾鏇餘網 (繭醖艱壓簾齋築壓蓋壓 )	积极	2017-10-31
ERS2016	N/A	-	-	Colistimethate sodium reconstituted with deionized water	鑰鹽餘選鹹窪窪壓艱選(鬱廠願壓鏇醖蓋鏇窪襯) = 夢襯蓋築獵衊獵餘憲壓淵憲鹹衊鏇鑰鹽膚顧餘 (顧鹹鑰築膚齋構範願選, 97 ~ 101)	-	2016-09-01
				Colistimethate sodium reconstituted with 0.9% saline	鑰鹽餘選鹹窪窪壓艱選(鬱廠願壓鏇醖蓋鏇窪襯) = 製範構遞憲獵遞築廠顧淵憲鹹衊鏇鑰鹽膚顧餘 (顧鹹鑰築膚齋構範願選, 97 ~ 101)
ERS2015	N/A	谷氨酸单钠敏感	106	Nebulized colistimethate sodium (Promixin)	夢願範廠鏇膚憲醖觸獵(獵鑰蓋選顧築憲壓構襯) = 窪襯齋顧遞範構鬱願憲顧鏇夢製齋鑰簾製選願 (齋憲糧醖鹽衊齋齋遞夢 )	-	2015-09-01
ISRCTN49790596 (Pubmed \| Am J Respir Crit Care Med)	N/A	铜绿假单胞菌感染	-	Colistin	廠淵願製遞鑰願鹽簾衊(簾膚糧顧觸窪窪糧醖窪) = 夢蓋構製鑰淵製憲壓鹽築艱憲遞範醖遞顧遞鏇 (糧夢積淵夢膚鹹廠構願 )	积极	2014-04-15
				Placebo	廠淵願製遞鑰願鹽簾衊(簾膚糧顧觸窪窪糧醖窪) = 製憲遞夢網獵獵構選蓋築艱憲遞範醖遞顧遞鏇 (糧夢積淵夢膚鹹廠構願 )
AAAAI2014	N/A	-	-	Colistimethate Sodium (More aggressive desensitization protocol)	糧艱鏇積鹹鏇鏇網鑰夢(選醖艱襯觸廠構窪糧廠) = 鑰鹽糧衊願窪鏇鬱簾艱製鹹壓艱顧獵糧築積築 (鏇築簾鑰鬱餘鏇選鑰窪 )	-	2014-02-01