The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)
作者: Fiona BolandMichael QuirkeBrenda GannonSinead PlunkettJohn HaydenJohn McCourtRonan O’SullivanJoseph EustaceConor DeasyAbel Wakai
作者单位: 1Royal College of Surgeons in Ireland (RCSI)
2Emergency Care Research Unit (ECRU), Division of Population Health Sciences, RCSI
3The University of Queensland
4School of Pharmacy, RCSI
5Clinical Research Centre, RCSI Education and Research Centre, Beaumont Hospital
6National Children’s Research Centre, Our Lady’s Children’s Hospital
7Cork University Hospital
8Beaumont Hospital
刊名: Trials, 2017, Vol.18 (1)
来源数据库: Springer Nature Journal
DOI: 10.1186/s13063-017-2121-2
关键词: CellulitisWound infectionAbscessFlucloxacillinPhenoxymethylpenicillinRandomised controlled trialEmergency departmentStatistical analysis plan
英文摘要: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here.
原始语种摘要: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here.
全文获取路径: Springer Nature  (合作)
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来源刊物:
影响因子:2.206 (2012)

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关键词翻译
关键词翻译
  • trial 试验
  • flucloxacillin 氟氯西林
  • SAP Security Assistance Program
  • analysis 分析
  • subdermal 皮下的
  • treatment 处理
  • cellulitis 蜂窝织炎
  • inferiority 下等
  • department 
  • painful 痛苦的