Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan
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- 作者：Willeke F Westendorp (2)
Jan-Dirk Vermeij (2)
Diederik W J Dippel (4)
Marcel G W Dijkgraaf (3)
Tom van der Poll (5) (6)
Jan M Prins (5) (6)
Frederique H Vermeij (7)
Yvo B W E M Roos (2)
Matthijs C Brouwer (2) (5)
Aeilko H Zwinderman (8)
Diederik van de Beek (2) (5)
Paul J Nederkoorn (2)
2. Department of Neurology ; Academic Medical Center ; P.O. Box 22660 ; 1100 DD ; Amsterdam ; the Netherlands
4. Department of Neurology ; Erasmus MC University Medical Center ; P.O. Box Postbus 2040 ; 3000 CA ; Rotterdam ; the Netherlands
3. Clinical Research Unit (CRU) ; Academic Medical Center ; P.O. Box 22660 ; 1100 DD ; Amsterdam ; the Netherlands
5. Department of Neurology ; Center of Infection and Immunity (CINIMA) ; Academic Medical Center ; P.O. Box 22660 ; 1100 DD ; Amsterdam ; the Netherlands
6. Department of Infectious Diseases ; Academic Medical Center ; P.O Box 22660 ; 1100 DD ; Amsterdam ; the Netherlands
7. Department of Neurology ; Sint Franciscus Gasthuis ; P.O. Box 10900 ; 3004 BA ; Rotterdam ; the Netherlands
8. Department of Clinical Epidemiology Biostatistics and Bioinformatics ; Academic Medical Center ; P.O. Box 22660 ; 1100 DD ; Amsterdam ; the Netherlands - 关键词：stroke ; infection ; antibiotics ; randomized clinical trial ; statistical analysis plan
- 刊名：Trials
- 出版年：2014
- 出版时间：December 2014
- 年：2014
- 卷：15
- 期：1
- 全文大小：1,083 KB
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- 出版者：BioMed Central
- ISSN：1745-6215
文摘
Background Infections occur in 30% of stroke patients and are associated with unfavorable outcomes. Preventive antibiotic therapy lowers the infection rate after stroke, but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown. The PASS is a multicenter, prospective, phase three, randomized, open-label, blinded end-point (PROBE) trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to standard stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections. This paper presents in detail the statistical analysis plan (SAP) of the Preventive Antibiotics in Stroke Study (PASS) and was submitted while the investigators were still blinded for all outcomes. Results The primary outcome is the score on the modified Rankin Scale (mRS), assessed by ordinal logistic regression analysis according to a proportional odds model. Secondary analysis of the primary outcome is the score on the mRS dichotomized as a favorable outcome (mRS 0 to 2) versus unfavorable outcome (mRS 3 to 6). Secondary outcome measures are death rate at discharge and 3 months, infection rate during hospital admission, length of hospital admission, volume of post-stroke care, use of antibiotics during hospital stay, quality-adjusted life years and costs. Complications of treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are reported as safety outcomes. Conclusions The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP. Trial registration Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.