Preventive antibiotics in stroke study: rationale and protocol for a randomised trial
Preventive antibiotics in stroke study: rationale and protocol for a randomised trial
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DOI：
10.1111/j.1747-4949.2010.00555.x
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发表时间：
2011-04-01
影响因子：
6.7
通讯作者：
van de Beek, Diederik
中科院分区：
文献类型：
--
作者：
Nederkoorn, Paul J.;Westendorp, Willeke F.;van de Beek, Diederik
中风是世界范围内的主要死亡原因。中风后发热是预后不良的一个强有力的预测因素。高达40%的中风患者发生感染，并且也与不良结局相关。预防性抗生素治疗可降低卒中后患者的感染率，如最近随机研究的荟萃分析所示。然而，到目前为止，还没有在足够数量的卒中患者中进行评估抗生素预防对临床结局影响的III期试验。头孢曲松是一种非专利药，是一种抗生素，对中风后最常见的感染细菌有广泛的防御作用。预防性应用头孢曲松钠可能会减少急性卒中后的不良预后，因此，一项随机临床试验是必要的。目的本研究的目的是调查预防性应用头孢曲松钠是否能改善卒中患者的功能预后。设计我们将进行一项多中心前瞻性、随机、开放标签、标准治疗加预防性头孢曲松治疗的盲法终点试验，并与不加预防性头孢曲松的标准治疗进行比较。（缺血性和出血性）和国立卫生研究院卒中量表评分>= 1的患者。3200例患者将被随机分配到两组，每组1600例患者。一组将接受标准护理和头孢曲松钠的剂量为2克，每24小时静脉注射4天，另一组将接受卒中单元护理，没有预防性抗生素treatment.OutcomesThe主要终点将是功能结果在3个月的后续修改兰金量表，二分法作为一个有利的结果（0-2）或不利的结果（3-6）。次要结局指标为出院时和3个月时的死亡率、住院期间的感染率、住院时间、卒中后护理量、3个月随访期间的抗生素使用情况、使用改良兰金量表完整顺序评分范围的功能结局、质量调整生命年和成本。
RationaleStroke is a leading cause of death worldwide. Fever after stroke is a strong predictor of a poor outcome. Infections occur in up to 40% of patients with stroke and have also been associated with poor outcomes. Preventive antibiotic therapy lowers the infection rates in patients after stroke, as shown in a recent meta-analysis of randomised studies. Phase III trials evaluating the effect of antibiotic prophylaxis on clinical outcomes in sufficient numbers of patients with stroke have, however, not been performed to date. Ceftriaxone, an off-patent medicine, is an antibiotic with a broad defence against the bacteria that cause the most common infections after stroke. Preventive antibiotic therapy with ceftriaxone may potentially reduce poor outcome after acute stroke and, therefore, a randomised clinical trial is warranted.AimThe aim of the present study is to investigate whether the preventive use of the antibiotic ceftriaxone improves functional outcome in patients with stroke.DesignWe will conduct a multicentre prospective, randomised, open-label, blinded end point trial of standard care with preventive ceftriaxone treatment and compare it with standard care without preventive ceftriaxone.StudyAdult patients with stroke (both ischaemic and haemorrhagic) and a score >= 1 on the National Institutes of Health Stroke Scale will be included. The 3200 patients will be randomly assigned to two groups of 1600 patients. One group will receive standard care and ceftriaxone at a dose of 2 g, given every 24 h intravenously for four-days, and the other group will receive stroke-unit care without preventive antibiotic treatment.OutcomesThe primary end point will be functional outcome at a three-month follow-up on the modified Rankin Scale, dichotomised as a favourable outcome (0-2) or an unfavourable outcome (3-6). Secondary outcome measures will be death rate at discharge and three-months, infection rate during hospital admission, length of hospital admission, volume of poststroke care, use of antibiotics during the three-month follow-up, functional outcome using the full ordinal scoring range of the modified Rankin Scale, quality-adjusted life years and costs.