减少老年人抗生素治疗的持续时间 (PROPAGE) (PROPAGE)
2022年4月25日 更新者：University Hospital, Grenoble
降钙素原在住院老人肺部感染中减少抗生素的持续时间：一项随机研究
主要目的是评估与传统临床策略相比，重复测量肺部感染患者降钙素原的益处，以减少抗生素治疗的持续时间。
研究概览
研究类型
介入性
注册 (实际的)
117
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rhone Alpes
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Grenoble、Rhone Alpes、法国、38000
- University Hospital Grenoble
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
80年 及以上 (OLDER_ADULT)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 年龄≥80岁
- 开始使用抗生素治疗胸部感染
- 降钙素原进行J0抗生素治疗
- 加入社会保障的人
排除标准：
- 在李斯特菌属、嗜肺军团菌、结核分枝杆菌后有细菌感染记录的患者
- 有病毒或寄生虫感染记录（如出血热、疟疾）的患者
- 伴有血管内感染的患者（心内膜炎、起搏器。 血管内导管）
- 入境时伴有肺脓肿的患者 伴有慢性感染的患者
- 患有严重免疫抑制（HIV 或移植）的患者
- 姑息治疗患者
- 进入护理单位后 24 小时内死亡。
- 存在针对慢性感染的抗生素治疗。
- 受监护、监管或任何其他行政或司法行为或被剥夺权利或自由的患者
- 未经本人同意住院的患者
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：平行线
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：降钙素原
每 2 天，他们将接受 PCT 剂量并根据算法 2 决定停止抗生素治疗。他们将在电子和所有不良事件报告表中通知临床评估结果。
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这些建议将基于 PCT 的级别：将给出 4 个级别的建议：
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NO_INTERVENTION：控制
只会进行和记录临床重新评估。
将列出抗生素数据和所有不良事件。
PCT 上从 D2 到 D4、D6、D8 和 D15 的数据将无法提供给处方者。
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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抗生素治疗的持续时间
大体时间：纳入后 45 天内抗生素治疗成功
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纳入后 45 天内抗生素治疗成功
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gaetan Gavazzi、University Clinic of Geriatrics Medicine, Division of Medicine multidisciplinary CHU de Grenoble,
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Micek ST, Ward S, Fraser VJ, Kollef MH. A randomized controlled trial of an antibiotic discontinuation policy for clinically suspected ventilator-associated pneumonia. Chest. 2004 May;125(5):1791-9. doi: 10.1378/chest.125.5.1791.
- el Moussaoui R, de Borgie CA, van den Broek P, Hustinx WN, Bresser P, van den Berk GE, Poley JW, van den Berg B, Krouwels FH, Bonten MJ, Weenink C, Bossuyt PM, Speelman P, Opmeer BC, Prins JM. Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study. BMJ. 2006 Jun 10;332(7554):1355. doi: 10.1136/bmj.332.7554.1355.
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- Gervaix A, Galetto-Lacour A, Gueron T, Vadas L, Zamora S, Suter S, Girardin E. Usefulness of procalcitonin and C-reactive protein rapid tests for the management of children with urinary tract infection. Pediatr Infect Dis J. 2001 May;20(5):507-11. doi: 10.1097/00006454-200105000-00007.
- Harbarth S, Holeckova K, Froidevaux C, Pittet D, Ricou B, Grau GE, Vadas L, Pugin J; Geneva Sepsis Network. Diagnostic value of procalcitonin, interleukin-6, and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J Respir Crit Care Med. 2001 Aug 1;164(3):396-402. doi: 10.1164/ajrccm.164.3.2009052.
- Gendrel D, Raymond J, Coste J, Moulin F, Lorrot M, Guerin S, Ravilly S, Lefevre H, Royer C, Lacombe C, Palmer P, Bohuon C. Comparison of procalcitonin with C-reactive protein, interleukin 6 and interferon-alpha for differentiation of bacterial vs. viral infections. Pediatr Infect Dis J. 1999 Oct;18(10):875-81. doi: 10.1097/00006454-199910000-00008.
- Chirouze C, Schuhmacher H, Rabaud C, Gil H, Khayat N, Estavoyer JM, May T, Hoen B. Low serum procalcitonin level accurately predicts the absence of bacteremia in adult patients with acute fever. Clin Infect Dis. 2002 Jul 15;35(2):156-61. doi: 10.1086/341023. Epub 2002 Jun 17.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年8月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2013年6月20日
首先提交符合 QC 标准的
2014年6月20日
首次发布 (估计)
2014年6月25日
研究记录更新
最后更新发布 (实际的)
2022年5月2日
上次提交的符合 QC 标准的更新
2022年4月25日
最后验证
2016年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.