Lack of Evidence for an Unmet Need to Treat Clostridium difficile Infection in Infants Aged <2 Years: Expert Recommendations on How to Address This Issue

被引：22
作者：
Faust, Saul N. [1 ,2 ]
Wilcox, Mark H. [3 ,4 ]
Banaszkiewicz, Aleksandra [5 ]
Bouza, Emilio [6 ]
Raymond, Josette [7 ]
Gerding, Dale N. [8 ,9 ]
机构：
[1] Univ Hosp Southampton NHS Fdn Trust, Natl Inst Hlth Res, Wellcome Trust Clin Res Facil, Southampton SO16 6YD, Hants, England
[2] Univ Southampton, Acad Unit Clin & Expt Sci, Southampton SO9 5NH, Hants, England
[3] Univ Leeds, Fac Med & Hlth, Leeds Teaching Hosp, Leeds LS2 9JT, W Yorkshire, England
[4] Univ Leeds, Fac Med & Hlth, Leeds Inst Biomed & Clin Sci, Leeds LS2 9JT, W Yorkshire, England
[5] Med Univ Warsaw, Dept Paediat Gastroenterol & Nutr, Warsaw, Poland
[6] Univ Complutense Madrid, Gregorio Maranon Hosp, Dept Med, Microbiol & Infect Dis Div, E-28040 Madrid, Spain
[7] Univ Rene Descartes Bacteriol, Paris, France
[8] Loyola Univ, Stritch Sch Med, Chicago, IL 60611 USA
[9] Hines Vet Affairs Hosp, Chicago, IL USA
来源：
CLINICAL INFECTIOUS DISEASES | 2015年 / 60卷 / 06期
关键词：
C. difficile infection; diarrhea; infants; pediatrics; clinical trial; PSEUDOMEMBRANOUS COLITIS; GUT MICROBIOTA; UNITED-STATES; CHILDREN; DIARRHEA; COMMUNITY; DISEASE; DESIGN;
D O I：
10.1093/cid/ciu936
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
The role of Clostridium difficile in causing disease in infants is unclear, and the existence of C. difficile infection (CDI) in this population is controversial. As part of the drug licensing process for new CDI therapies, a pediatric investigation plan is required to define studies in infants aged <2 years. This assumes an unmet medical need, even though clinical trials in this age group may not be feasible. Three pharmaceutical companies developing CDI treatments came together to seek advice from a panel of experts. Our unanimous opinion is that the existence of CDI is questionable in infants, and if it exists, is rare. There is therefore no unmet need for CDI treatment in this population. Interventional studies are not feasible with the current level of knowledge, and studies should be limited to noninterventional studies or open-label pharmacokinetic and safety studies to better define CDI in infants.
引用
收藏
页码：912 / 918
页数：7
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