Redefining Clostridioides difficile infection antibiotic response and clinical outcomes

被引：9

作者：

Gonzales-Luna, Anne J. ^{[1
]}

Skinner, Andrew M. ^{[2
,3
,4
]}

Alonso, Carolyn D. ^{[5
]}

Bouza, Emilio ^{[7
]}

Cornely, Oliver A. ^{[8
,9
,10
,11
,12
,13
]}

de Meij, Tim G. J. ^{[14
]}

Drew, Richard J. ^{[15
,16
,17
,18
]}

Garey, Kevin W. ^{[1
]}

Gerding, Dale N. ^{[3
,4
]}

Johnson, Stuart ^{[3
,4
]}

Kahn, Stacy A. ^{[19
]}

Kato, Haru ^{[21
]}

Kelly, Ciaran P. ^{[6
]}

Kelly, Colleen R. ^{[22
]}

Kociolek, Larry K. ^{[23
]}

Kuijper, Ed J. ^{[24
,29
]}

Louie, Thomas ^{[25
]}

Riley, Thomas, V ^{[26
]}

Sandora, Thomas J. ^{[20
]}

Vehreschild, Maria J. G. T. ^{[27
]}

Wilcox, Mark H. ^{[28
]}

Dubberke, Erik R. ^{[29
]}

机构：

[1] Univ Houston, Dept Pharm Practice & Translat Res, Coll Pharm, Houston, TX USA

[2] Loyola Univ Med Ctr, Dept Med, Maywood, IL USA

[3] Edward Hines Jr VA Hosp, Dept Med, Hines, IL USA

[4] Edward Hines Jr VA Hosp, Dept Res, Hines, IL USA

[5] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Div Infect Dis, Boston, MA USA

[6] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Div Gastroenterol, Dept Med, Boston, MA USA

[7] Univ Complutense, Dept Microbiol & Infect Dis, Madrid, Spain

[8] Univ Cologne, Translat Res, Cologne Excellence Cluster Cellular Stress Respon, Cologne, Germany

[9] Univ Cologne, Ctr Integrated Oncol Aachen Bonn Cologne Duesseld, Dept Internal Med, Cologne, Germany

[10] Univ Cologne, Excellence Ctr Med Mycol, Cologne, Germany

[11] Univ Cologne, Clin Trials Ctr Cologne, Fac Med, Cologne, Germany

[12] Univ Cologne, Univ Hosp Cologne, Cologne, Germany

[13] German Ctr Infect Res, Partner Site Bonn Cologne, Cologne, Germany

[14] Univ Amsterdam, Emma Childrens Hosp, Dept Pediat Gastroenterol, Med Ctr, Amsterdam, Netherlands

[15] Rotunda Hosp, Clin Innovat Unit, Dublin, Ireland

[16] Childrens Hlth Ireland, Dublin, Ireland

[17] Childrens Hlth Ireland, Irish Meningitis & Sepsis Reference Lab, Temple St, Dublin, Ireland

[18] Royal Coll Surgeons Ireland, Dept Microbiol, Dublin, Ireland

[19] Boston Childrens Hosp, Div Gastroenterol Hepatol & Nutr, Boston, MA USA

[20] Boston Childrens Hosp, Dept Pediat, Boston, MA USA

[21] Natl Inst Infect Dis, Antimicrobial Resistance Res Ctr, Tokyo, Japan

[22] Brown Univ, Dept Med, Warren Alpert Med Sch, Providence, RI USA

[23] Ann & Robert H Lurie Childrens Hosp Chicago, Div Pediat Infect Dis, Chicago, IL USA

[24] Leiden Univ, Dept Med Microbiol, Med Ctr, Leiden, Netherlands

[25] Univ Calgary, Dept Med, Infect Dis, Calgary, AB, Canada

[26] Univ Western Australia, Sch Biomed Sci, Crawley, WA, Australia

[27] Goethe Univ Frankfurt, Univ Hosp Frankfurt, Dept Internal Med, Infect Dis, Frankfurt, Germany

[28] Leeds Gen Infirm, Old Med Sch, Microbiol, Leeds, England

[29] European Soc Clin Microbiol & Infect Dis Study Gr, Basel, Switzerland

来源：

LANCET INFECTIOUS DISEASES | 2023年 / 23卷 / 07期

关键词：

HEALTH-CARE EPIDEMIOLOGY; DISEASES SOCIETY; AMERICA IDSA; VANCOMYCIN; METRONIDAZOLE; FIDAXOMICIN; PREVENTION; GUIDELINES; DIAGNOSIS; DIARRHEA;

D O I：

10.1016/S1473-3099(23)00047-6

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

With the approval and development of narrow-spectrum antibiotics for the treatment of Clostridioides difficile infection (CDI), the primary endpoint for treatment success of CDI antibiotic treatment trials has shifted from treatment response at end of therapy to sustained response 30 days after completed therapy. The current definition of a successful response to treatment (three or fewer unformed bowel movements [UBMs] per day for 1-2 days) has not been validated, does not reflect CDI management, and could impair assessments for successful treatment at 30 days. We propose new definitions to optimise trial design to assess sustained response. Primarily, we suggest that the initial response at the end of treatment be defined as (1) three or fewer UBMs per day, (2) a reduction in UBMs of more than 50% per day, (3) a decrease in stool volume of more than 75% for those with ostomy, or (4) attainment of bowel movements of Bristol Stool Form Scale types 1-4, on average, by day 2 after completion of primary CDI therapy (ie, assessed on day 11 and day 12 of a 10-day treatment course) and following an investigator determination that CDI treatment can be ceased.

引用

页码：E259 / E265

页数：7

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