White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs
White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs
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DOI：
10.1093/infdis/jix211
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发表时间：
2017-07-15
影响因子：
6.4
通讯作者：
Rex, John H.
中科院分区：
文献类型：
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作者：
Boucher, Helen W.;Ambrose, Paul G.;Rex, John H.
尽管抗微生物药物开发取得了进展，但仍然迫切需要开发新的可行途径来开发抗菌剂以治疗感染耐药菌的人。耐药革兰氏阴性杆菌引起的感染继续造成不可接受的发病率和死亡率。抗菌药物历来在非劣效性临床试验中进行研究，这些试验侧重于单一感染部位（例如，复杂性尿路感染、腹腔内感染），但这些设计对于耐药菌引起的感染研究可能不是最佳的，而且往往不可行。在过去的几年里，多个利益相关者一直致力于就前进道路达成共识，目标是促进及时进行抗菌剂开发。在这里，我们提倡一种新颖而务实的方法，并为此目的，提出了可行的抗菌药物试验设计，可以进行窄谱，生物体特异性临床试验，并最终批准急需的新抗菌药物。
Despite progress in antimicrobial drug development, a critical need persists for new, feasible pathways to develop antibacterial agents to treat people infected with drug-resistant bacteria. Infections due to resistant gram-negative bacilli continue to cause unacceptable morbidity and mortality rates. Antibacterial agents have been historically studied in noninferiority clinical trials that focus on a single site of infection (eg, complicated urinary tract infections, intra-abdominal infections), yet these designs may not be optimal, and often are not feasible, for study of infections caused by drug-resistant bacteria. Over the past several years, multiple stakeholders have worked to develop consensus regarding paths forward with a goal of facilitating timely conduct of antimicrobial development. Here we advocate for a novel and pragmatic approach and, toward this end, present feasible trial designs for antibacterial agents that could enable conduct of narrow-spectrum, organism-specific clinical trials and ultimately approval of critically needed new antibacterial agents.