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Short Versus Long Antibiotic Course for Pleural Infection Management (SLIM Trial) (SLIM)

2021年12月18日 更新者:Alexandria University

Short Versus Long Antibiotic Course for Pleural Infection Management (SLIM Trial): a Randomized Controlled Open Label Trial

Infection of the pleural space is serious condition that requires hospitalization, invasive interventions and long courses of antibiotics[1]. Treatment of pleural infection requires long hospital admission with a median of 19 days[2] and medical treatments fails requiring surgical intervention in up to 30% of cases[3]. The mortality from pleural infection is around 10% at 3 months[4].

Besides drainage of the infected fluid, antibiotics are a core component of management of pleural infection[5] and are typically given intravenously in the first few days of treatment until the condition is stabilized at which stage patients are shifted to oral antibiotics of equivalent spectrum. In almost half of the cases of pleural infection, the choice of antibiotics is entirely empirical due to low yield of microbiological tests on pleural fluid in these cases[6]. International guidelines cite a minimum length of antibiotic course of pleural infection of four weeks[5,7] with antibiotic courses typically lasting six weeks[8]. However, these recommendations are based on expert opinion with no robust evidence to support such durations.

The RAPID (renal function, age, purulence, infection source and dietary factors) score has recently been validated as a robust tool to predict 3-month mortality of patients with pleural infection based on demographic and laboratory data (table 1)[4]. A low score (0-2) is associated with 2-3% mortality, medium score (3-4) 9% mortality and high score (5-7) 30% mortality at three months[9]. The utility for this score in clinical management is yet to be determined and this study will attempt using this score to stratify lengths of antibiotic treatment based on proposed risk of adverse outcomes as stipulated by the RAPID score.

The aim of this study is to investigate the feasibility and safety of prescribing shorter courses of antibiotics (2-3 weeks) versus the standard longer courses (4-6 weeks) in medically-treated patients with pleural infection at lower risk of mortality (RAPID score 0-4) who can be safely discharged home within 14 days of hospitalization and how this impacts success of medical treatment.

研究概览

详细说明

Infection of the pleural space is serious condition that requires hospitalization, invasive interventions and long courses of antibiotics. Treatment of pleural infection requires long hospital admission with a median of 19 days and medical treatments fails requiring surgical intervention in up to 30% of cases. The mortality from pleural infection is around 10% at 3 months.

Besides drainage of the infected fluid, antibiotics are a core component of management of pleural infection and are typically given intravenously in the first few days of treatment until the condition is stabilized at which stage patients are shifted to oral antibiotics of equivalent spectrum. In almost half of the cases of pleural infection, the choice of antibiotics is entirely empirical due to low yield of microbiological tests on pleural fluid in these cases. International guidelines cite a minimum length of antibiotic course of pleural infection of four weeks with antibiotic courses typically lasting six weeks[8]. However, these recommendations are based on expert opinion with no robust evidence to support such durations. A recent trial compared a two-week versus a three-week antibiotic course for parapneumonic pleural infections. The trial that concluded prematurely due to inability to recruit to target sample size and found that the two regimens were equivalent in terms of risk of failure of medical treatment. Besides being an underpowered study, the results are only applicable to parapneumonic effusions but not primary pleural infections.

The RAPID score has recently been validated as a robust tool to predict 3-month mortality of patients with pleural infection based on demographic and laboratory data. A low score (0-2) is associated with 2-3% mortality, medium score (3-4) 9% mortality and high score (5-7) 30% mortality at three months. The utility for this score in clinical management is yet to be determined and this study will attempt using this score to stratify lengths of antibiotic treatment based on proposed risk of adverse outcomes as stipulated by the RAPID score. A shorter antibiotic course that is as effective as the standard long course is desirable given the common occurrence of side effects with antibiotic treatment. The presence of a robust predictive score of outcome seems as an attractive tool to help stratify patients who can be safely treated with shorter antibiotic courses.

The aim of this study is to investigate the feasibility and safety of prescribing shorter courses of antibiotics (2-3 weeks) versus the standard longer courses (4-6 weeks) in medically-treated patients with pleural infection at lower risk of mortality (RAPID score 0-4) who can be safely discharged home within 14 days of hospitalization and how this impacts success of medical treatment.

研究类型

介入性

注册 (实际的)

50

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

      • Alexandria、埃及
        • Alexandria University Faculty of Medicine

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients (>18 years old)
  • Willing to provide informed consent
  • Admitted to hospital for treatment of pleural infection (both parapneumonic and primary pleural infections included). Pleural infection will be defined by the presence of one of the following:

    1. the presence of pus in the pleural space;
    2. positive pleural fluid gram stain or culture; or
    3. pleural fluid pH < 7.2 or pleural fluid glucose < 40 mg/dL in the setting of acute respiratory infection.
  • RAPID low or intermediate score (0-4)
  • Fit for discharge within 14th day of admission

Exclusion Criteria:

  • Failure of medical treatment within 14 days of admission and need for surgical referral
  • Need for hospital admission beyond 14 days due to medical reasons
  • Admission to recurrent ipsilateral pleural infection within the last three months
  • RAPID high score (5 or more)
  • Pleural infection not amenable to drainage at time of diagnosis and therefore upfront decision to treat with prolonged antibiotics
  • Residual pleural collection (despite attempted drainage) that the managing clinician indicated is for prolonged oral suppressive therapy (i.e. six weeks of oral antibiotics).

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Short course
Antibiotic course of 2-3 weeks overall duration for treating pleural infection
Shorter course of antibiotic than standard care of 4-6 weeks
有源比较器:Long course
Antibiotic course of 4-6 weeks overall duration for treating pleural infection
4-6 weeks of antibiotics

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants with failure of medical treatment
大体时间:Outcome assessed at six weeks post diagnosis
Incidence of failure of treatment as judged by trial clinician requiring further antibiotics and/or tube drainage and/or surgical intervention by six weeks post initial admission. Failure will be determined based on the one or more of the following parameter: clinical (recurrence of symptoms), biochemical (worsening of WCC [by 2000/mm3] or CRP [by > 20%] from discharge values) and radiological (chest X-ray +/- TUS evidence of increasing or new pleural collection).
Outcome assessed at six weeks post diagnosis

次要结果测量

结果测量
措施说明
大体时间
Length of antibiotic treatment in days
大体时间:Outcome assessed at six weeks post diagnosis
Total length of antibiotic treatment (in days) in the study arms
Outcome assessed at six weeks post diagnosis
Number of participants with chest X ray worsening at 6 weeks
大体时间:Outcome assessed at six weeks post diagnosis
Number of participants with worsening in the 6-week chest X-ray as compared to discharge chest X-ray in the study arms. Chest X-ray pairs (discharge vs 6-week) will be read by a respiratory physician blinded to treatment allocation who will judge whether there is worsening (versus stability or improvement)
Outcome assessed at six weeks post diagnosis
Time to return to normal daily activities in days
大体时间:Outcome assessed at six weeks post diagnosis
Time (in days) to return to normal daily activities in participants of the study arms
Outcome assessed at six weeks post diagnosis
Number of participants requiring readmission within 30 days from discharge
大体时间:30 days from discharge
Readmission within 30 days from discharge
30 days from discharge

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:Maged Hassan, PhD、Alexandria University Faculty of Medicine

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

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)

2020年9月28日

初级完成 (实际的)

2021年11月10日

研究完成 (实际的)

2021年12月6日

研究注册日期

首次提交

2020年10月14日

首先提交符合 QC 标准的

2020年11月2日

首次发布 (实际的)

2020年11月4日

研究记录更新

最后更新发布 (实际的)

2021年12月21日

上次提交的符合 QC 标准的更新

2021年12月18日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • 3/24/11/10/2020

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The spreadsheets with de-identified patient information will be stored securely after trial conclusion with the principal investigator and will be accessible to other members of the study team. Request to access study data by persons outside the study teams will be expected via email and access will be granted by the principal investigator if the request is deemed reasonable.

IPD 共享时间框架

5 years after study completion

IPD 共享访问标准

The data that support the findings of this study will be available on request from the corresponding author upon publishing the manuscript with the main results.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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