在 I、II 或 III 期临床试验中对革兰氏阴性杆菌有效的抗菌剂。

IF 4.9 2区 医学 Q1 PHARMACOLOGY & PHARMACY Expert opinion on investigational drugs Pub Date : 2024-04-01 Epub Date: 2024-03-06 DOI:10.1080/13543784.2024.2326028
David L Paterson
{"title":"在 I、II 或 III 期临床试验中对革兰氏阴性杆菌有效的抗菌剂。","authors":"David L Paterson","doi":"10.1080/13543784.2024.2326028","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Antimicrobial resistance is a major threat to modern healthcare, and it is often regarded that the antibiotic pipeline is 'dry.'</p><p><strong>Areas covered: </strong>Antimicrobial agents active against Gram negative bacilli in Phase I, II, or III clinical trials were reviewed.</p><p><strong>Expert opinion: </strong>Nearly 50 antimicrobial agents (28 small molecules and 21 non-traditional antimicrobial agents) active against Gram-negative bacilli are currently in clinical trials. These have the potential to provide substantial improvements to the antimicrobial armamentarium, although it is known that 'leakage' from the pipeline occurs due to findings of toxicity during clinical trials. Significantly, a lack of funding for large phase III clinical trials is likely to prevent trials occurring for the indications most relevant to loss of life attributed to antimicrobial resistance such as ventilator-associated pneumonia. Non-traditional antimicrobial agents face issues in clinical development such as a lack of readily available and reliable susceptibility tests, and the potential need for superiority trials rather than non-inferiority trials. Most importantly, concrete plans must be made during clinical development for access of new antimicrobial agents to areas of the world where resistance to Gram negative bacilli is most frequent.</p>","PeriodicalId":12313,"journal":{"name":"Expert opinion on investigational drugs","volume":null,"pages":null},"PeriodicalIF":4.9000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Antibacterial agents active against Gram Negative Bacilli in phase I, II, or III clinical trials.\",\"authors\":\"David L Paterson\",\"doi\":\"10.1080/13543784.2024.2326028\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Antimicrobial resistance is a major threat to modern healthcare, and it is often regarded that the antibiotic pipeline is 'dry.'</p><p><strong>Areas covered: </strong>Antimicrobial agents active against Gram negative bacilli in Phase I, II, or III clinical trials were reviewed.</p><p><strong>Expert opinion: </strong>Nearly 50 antimicrobial agents (28 small molecules and 21 non-traditional antimicrobial agents) active against Gram-negative bacilli are currently in clinical trials. These have the potential to provide substantial improvements to the antimicrobial armamentarium, although it is known that 'leakage' from the pipeline occurs due to findings of toxicity during clinical trials. Significantly, a lack of funding for large phase III clinical trials is likely to prevent trials occurring for the indications most relevant to loss of life attributed to antimicrobial resistance such as ventilator-associated pneumonia. Non-traditional antimicrobial agents face issues in clinical development such as a lack of readily available and reliable susceptibility tests, and the potential need for superiority trials rather than non-inferiority trials. Most importantly, concrete plans must be made during clinical development for access of new antimicrobial agents to areas of the world where resistance to Gram negative bacilli is most frequent.</p>\",\"PeriodicalId\":12313,\"journal\":{\"name\":\"Expert opinion on investigational drugs\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert opinion on investigational drugs\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/13543784.2024.2326028\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert opinion on investigational drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/13543784.2024.2326028","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/6 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

简介:抗菌药耐药性是对现代医疗保健的一大威胁,人们通常认为抗生素管道已经 "干涸":专家意见:目前有近 50 种对革兰氏阴性杆菌有效的抗菌药物(28 种小分子药物和 21 种非传统抗菌药物)正在进行临床试验。尽管众所周知,由于临床试验中发现的毒性,这些药物有可能从管道中 "流失"。值得注意的是,由于缺乏用于大型 III 期临床试验的资金,因此可能无法针对与抗菌药耐药性导致的生命损失最相关的适应症(如呼吸机相关性肺炎)进行试验。非传统抗菌药物在临床开发中面临一些问题,如缺乏现成可靠的药敏试验,以及可能需要进行优效试验而非劣效试验。最重要的是,在临床开发过程中,必须制定具体计划,让新的抗菌药物进入世界上革兰阴性杆菌耐药性最常见的地区。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Antibacterial agents active against Gram Negative Bacilli in phase I, II, or III clinical trials.

Introduction: Antimicrobial resistance is a major threat to modern healthcare, and it is often regarded that the antibiotic pipeline is 'dry.'

Areas covered: Antimicrobial agents active against Gram negative bacilli in Phase I, II, or III clinical trials were reviewed.

Expert opinion: Nearly 50 antimicrobial agents (28 small molecules and 21 non-traditional antimicrobial agents) active against Gram-negative bacilli are currently in clinical trials. These have the potential to provide substantial improvements to the antimicrobial armamentarium, although it is known that 'leakage' from the pipeline occurs due to findings of toxicity during clinical trials. Significantly, a lack of funding for large phase III clinical trials is likely to prevent trials occurring for the indications most relevant to loss of life attributed to antimicrobial resistance such as ventilator-associated pneumonia. Non-traditional antimicrobial agents face issues in clinical development such as a lack of readily available and reliable susceptibility tests, and the potential need for superiority trials rather than non-inferiority trials. Most importantly, concrete plans must be made during clinical development for access of new antimicrobial agents to areas of the world where resistance to Gram negative bacilli is most frequent.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
10.00
自引率
0.00%
发文量
71
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Investigational Drugs (ISSN 1354-3784 [print], 1744-7658 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on drugs in preclinical and early stage clinical development, providing expert opinion on the scope for future development. The Editors welcome: Reviews covering preclinical through to Phase II data on drugs or drug classes for specific indications, and their potential impact on future treatment strategies Drug Evaluations reviewing the clinical and pharmacological data on a particular drug Original Research papers reporting the results of clinical investigations on agents that are in Phase I and II clinical trials The audience consists of scientists, managers and decision-makers in the pharmaceutical industry, and others closely involved in R&D.
期刊最新文献
Promising selective progesterone receptor modulators: what's new in female contraception? Targeting a key FAK-tor: the therapeutic potential of combining focal adhesion kinase (FAK) inhibitors and chemotherapy for chemoresistant non-small cell lung cancer. Dual blockade of endothelin A and angiotensin II type 1 receptors with sparsentan as a novel treatment strategy to alleviate IgA nephropathy. Management of inflammaging in kidney diseases: focusing on the current investigational drugs. Protein phosphatase 2A activators under investigation for smoking-related chronic obstructive pulmonary disease and related disorders.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1