1. Update of the Preventive Antibiotics in Stroke Study (PASS): Statistical analysis plan
- Author
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Westendorp, W.F. (Willeke), Vermeij, J.-D. (Jan-Dirk), Dippel, D.W.J. (Diederik), Dijkgraaf, M.G.W. (Marcel), Poll, T. (Tom) van der, Prins, J.M. (Jan), Vermeij, F.H. (Frederique), Roos, Y.B.W.E.M. (Yvo), Brouwer, M.C. (Matthijs), Zwinderman, A.H. (Ailko), Beek, D. (Diederik) van de, Nederkoorn, P.J. (Paul), Westendorp, W.F. (Willeke), Vermeij, J.-D. (Jan-Dirk), Dippel, D.W.J. (Diederik), Dijkgraaf, M.G.W. (Marcel), Poll, T. (Tom) van der, Prins, J.M. (Jan), Vermeij, F.H. (Frederique), Roos, Y.B.W.E.M. (Yvo), Brouwer, M.C. (Matthijs), Zwinderman, A.H. (Ailko), Beek, D. (Diederik) van de, and Nederkoorn, P.J. (Paul)
- Abstract
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 sti
- Published
- 2014
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