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

被引：88

作者：

Spellberg, Brad ^{[1
]}

Brass, Eric P. ^{[2
,3
]}

Lewis, Roger J. ^{[4
]}

Shlaes, David

Ambrose, Paul G.

Das, Anita

Boucher, Helen ^{[5
]}

Bradley, John ^{[6
,7
]}

Doi, Yohei ^{[8
]}

Bartlett, John ^{[9
]}

Bonomo, Robert A. ^{[10
]}

Larosa, Steven ^{[11
]}

Talbot, George H. ^{[12
]}

Benjamin, Daniel ^{[13
]}

Guidos, Robert J.

Jezek, Amanda

Gilbert, David N. ^{[14
]}

机构：

[1] Harbor UCLA Med Ctr, Los Angeles Biomed Res Inst, Div Gen Internal Med, Los Angeles, CA USA

[2] Univ Calif Los Angeles, David Geffen Sch Med, Dept Med, Los Angeles, CA 90095 USA

[3] Harbor UCLA Ctr Clin Pharmacol, Los Angeles, CA USA

[4] Univ Calif Los Angeles, David Geffen Sch Med, Dept Emergency Med, Harbor UCLA Med Ctr,Los Angeles Biomed Res Inst, Los Angeles, CA 90095 USA

[5] Tufts Univ, Sch Med, Medford, MA 02155 USA

[6] Univ Calif San Diego, San Diego, CA 92103 USA

[7] Rady Childrens Hosp San Diego, San Diego, CA USA

[8] Univ Pittsburgh, Sch Med, Div Infect Dis, Pittsburgh, PA 15260 USA

[9] Johns Hopkins Univ, Sch Med, Baltimore, MD 21218 USA

[10] Case Western Reserve Univ, Sch Med, Louis A Stokes VA Med Ctr, Cleveland, OH 44106 USA

[11] Beverly Hosp, Beverly, MA USA

[12] Talbot Advisors LLC, Anna Maria, FL USA

[13] Duke Univ, Sch Med, Durham, NC 27706 USA

[14] Providence Portland Med Ctr, Portland, OR USA

来源：

CLINICAL INFECTIOUS DISEASES | 2012年 / 55卷 / 08期

基金：

美国国家卫生研究院;

关键词：

ACINETOBACTER-BAUMANNII INFECTIONS; PSEUDOMONAS-AERUGINOSA BACTEREMIA; POPULATION PHARMACOKINETICS; NEISSERIA-GONORRHOEAE; ANTIBIOTIC-RESISTANCE; SCAVENGED SAMPLES; PNEUMONIA; TIGECYCLINE; DAPTOMYCIN; THERAPY;

D O I：

10.1093/cid/cis688

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：1031 / 1046

页数：16

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