White Paper: Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens
White Paper: Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens
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DOI：
10.1093/cid/cis688
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发表时间：
2012-10-15
影响因子：
11.8
通讯作者：
Gilbert, David N.
中科院分区：
文献类型：
--
作者：
Spellberg, Brad;Brass, Eric P.;Gilbert, David N.
目前迫切需要新的途径来开发抗菌剂，以治疗由高度耐药细菌引起的危及生命的感染。传统上，抗菌药物是在非劣效性临床试验中研究的，主要集中在一个感染部位（如肺炎、腹腔感染）。对高度耐药细菌引起的感染进行优势试验代表了抗菌药物开发的一种新的、尚未经过测试的范式。我们试图确定抗菌药物的可行试验设计，使其能够进行优势和生物体特异性临床试验。这些建议是白皮书起草者、外部合作者和监管官员多年来积极对话的结果。我们的目标是促进进行新型抗菌临床试验，以开发并最终批准急需的新型抗菌药物。
There is a critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria. Traditionally, antibacterial agents have been studied in noninferiority clinical trials that focus on one site of infection (eg, pneumonia, intra-abdominal infection). Conduct of superiority trials for infections caused by highly antibiotic-resistant bacteria represents a new, and as yet, untested paradigm for antibacterial drug development. We sought to define feasible trial designs of antibacterial agents that could enable conduct of superiority and organism-specific clinical trials. These recommendations are the results of several years of active dialogue among the white paper's drafters as well as external collaborators and regulatory officials. Our goal is to facilitate conduct of new types of antibacterial clinical trials to enable development and ultimately approval of critically needed new antibacterial agents.