Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations
Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations
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DOI：
10.1093/cid/ciz899
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发表时间：
2020-04-01
影响因子：
11.8
通讯作者：
Deal, Carolyn
中科院分区：
文献类型：
--
作者：
Hook, Edward W., III;Newman, Lori;Deal, Carolyn
淋病仍然是一个重大的公共卫生挑战，当前的淋病治疗建议受到抗菌素耐药性不断演变和新抗生素研发渠道减少的威胁。目前，对淋病潜在新疗法的评估仅有限地利用了对有效治疗、预防抗菌药物耐药性的药代动力学和药效学影响因素的新认识，以及临床试验的新设计。他们因在旨在寻求淋病治疗适应症的非劣效性试验中使用头孢曲松/阿奇霉素联合治疗作为比较方案的要求而受到阻碍。不断变化的淋球菌流行病学和临床试验设计限制阻碍了淋病风险最大的人群（青少年、妇女和感染耐抗生素淋病奈瑟菌的人）的招募。本文总结了最近一次关于泌尿生殖淋病治疗抗菌药物评估过程的会议，并鼓励考虑淋病治疗评估的新设计。
Gonorrhea remains a major public health challenge, and current recommendations for gonorrhea treatment are threatened by evolving antimicrobial resistance and a diminished pipeline for new antibiotics. Evaluations of potential new treatments for gonorrhea currently make limited use of new understanding of the pharmacokinetic and pharmacodynamic contributors to effective therapy, the prevention of antimicrobial resistance, and newer designs for clinical trials. They are hampered by the requirement to utilize combination ceftriaxone/azithromycin therapy as the comparator regimen in noninferiority trials designed to seek an indication for gonorrhea therapy. Evolving gonococcal epidemiology and clinical trial design constraints hinder the enrollment of those populations at the greatest risk for gonorrhea (adolescents, women, and persons infected with antibiotic-resistant Neisseria gonorrhoeae). This article summarizes a recent meeting on the evaluation process for antimicrobials for urogenital gonorrhea treatment and encourages the consideration of new designs for the evaluation of gonorrhea therapy.