GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial: rationale and study protocol for a randomised controlled trial.
GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial: rationale and study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-018-2971-2
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发表时间：
2018-11-08
期刊：
影响因子：
2.5
通讯作者：
Morimoto T
中科院分区：
文献类型：
--
作者：
Yoshimura J;Yamakawa K;Kinoshita T;Ohta Y;Morimoto T
优化抗生素的使用是克服重症监护病房（ICU）中多重耐药病原体快速出现和传播的紧迫挑战。尽管革兰氏染色可能为预测致病菌提供直接信息，但革兰氏染色指导的初始抗生素治疗在ICU环境中尚未得到很好的建立。我们计划进行呼吸机相关性肺炎（GRACE-VAP）的革兰氏染色指导抗生素选择试验，以研究革兰氏染色是否可以安全地限制呼吸机相关性肺炎（VAP）患者使用广谱抗生素，VAP是ICU中最常见的医院获得性感染之一。GRACE-VAP试验是一项多中心、随机、开放标签、平行组试验，旨在评估革兰氏染色指导的初始抗生素治疗相对于基于指南的初始抗生素治疗在VAP患者临床应答率主要终点方面的非劣效性。次要终点包括初始抗生素治疗的覆盖率、抗假单胞菌药物和抗耐甲氧西林金黄色葡萄球菌（抗MRSA）药物作为初始抗生素治疗的选择率、28天全因死亡率、无ICU天数、无呼吸机天数和不良事件。患者以1：1的比例随机分配接受革兰氏染色指导治疗或基于指南的治疗。在革兰氏染色组中，气管内抽吸物的革兰氏染色结果用于指导抗生素的选择。在指南组中，施用抗假单胞菌剂和抗MRSA剂的组合。考虑到10%的患者不可评价，估计总样本量为200，可提供80%的把握度，单侧α水平为2.5%，非劣效性界值为20%。GRACE-VAP试验预计将揭示革兰氏染色是否可以减少广谱抗生素的使用而不损害患者的结局，从而为VAP患者的抗生素选择策略提供证据。Clinicaltrials.gov，NCT 03506113。于2018年3月29日注册。大学医院医疗信息网络，UMIN 000031933。于2018年3月26日注册。本文的在线版本（10.1186/s13063-018-2971-2）包含补充材料，可供授权用户使用。
Optimising the use of antibiotic agents is a pressing challenge to overcoming the rapid emergence and spread of multidrug-resistant pathogens in intensive care units (ICUs). Although Gram staining may possibly provide immediate information for predicting pathogenic bacteria, Gram stain-guided initial antibiotic treatment is not well established in the ICU setting. We planned the GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial to investigate whether Gram staining can safely restrict the use of broad-spectrum antibiotics in patients with ventilator-associated pneumonia (VAP), which is one of the most common hospital-acquired infections in ICUs. The GRACE-VAP trial is a multicentre, randomised, open-label parallel-group trial to assess the non-inferiority of Gram stain-guided initial antibiotic treatment to guidelines-based initial antibiotic treatment for the primary endpoint of clinical response rate in patients with VAP. Secondary endpoints include the coverage rates of initial antibiotic therapies, the selected rates of anti-pseudomonal agents and anti-methicillin-resistant Staphylococcus aureus (anti-MRSA) agents as initial antibiotic therapies, 28-day all-cause mortality, ICU-free days, ventilator-free days and adverse events. Patients are randomly assigned to receive Gram stain-guided treatment or guidelines-based treatment at a ratio of 1:1. In the Gram stain group, results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics. In the guidelines group, the combination of an anti-pseudomonal agent and an anti-MRSA agent is administered. A total sample size of 200 was estimated to provide a power of 80% with a one-sided alpha level of 2.5% and a non-inferiority margin of 20%, considering 10% non-evaluable patients. The GRACE-VAP trial is expected to reveal whether Gram staining can reduce the use of broad-spectrum antibiotics without impairing patient outcomes and thereby provide evidence for an antibiotic selection strategy in patients with VAP. Clinicaltrials.gov, NCT03506113. Registered on 29 March 2018. University Hospital Medical Information Network, UMIN000031933. Registered on 26 March 2018. The online version of this article (10.1186/s13063-018-2971-2) contains supplementary material, which is available to authorized users.
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影响因子：
11.8
作者：
Kalil, Andre C.;Metersky, Mark L.;Brozek, Jan L.
通讯作者：
Brozek, Jan L.
影响因子：
6.9
作者：
Tetenta, Sodienye;Metersky, Mark L.
通讯作者：
Metersky, Mark L.
影响因子：
158.5
作者：
Fowler, Vance G., Jr.;Boucher, Helen W.;Cosgrove, Sara E.
通讯作者：
Cosgrove, Sara E.
影响因子：
2.2
作者：
Seligman R;Seligman BG;Konkewicz L;Dos Santos RP
通讯作者：
Dos Santos RP
DOI：
10.1093/cid/ciq031
发表时间：
2011-01-01
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
Rubinstein E;Lalani T;Corey GR;Kanafani ZA;Nannini EC;Rocha MG;Rahav G;Niederman MS;Kollef MH;Shorr AF;Lee PC;Lentnek AL;Luna CM;Fagon JY;Torres A;Kitt MM;Genter FC;Barriere SL;Friedland HD;Stryjewski ME;ATTAIN Study Group
通讯作者：
ATTAIN Study Group