The Benefit of Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography in the Treatment Algorithm of Staphylococcus Aureus Bacteremia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Management changes triggered by PET CT (percentage of management changes triggered by PET CT will be documented per patient group)
研究概览
简要总结
Background: Staphylococcus aureus bacteremia (SAB) is frequently encountered in hospitals, with high rates of morbidity and mortality. Duration of antimicrobial treatment for SAB, other than in cases of Infective endocarditis (IE), recommended by different guidelines relies on risk stratification for relapse of infection rather than definite diagnosis of septic foci that eventually determine the relapse rate. In recently published studies fluorodeoxyglucose (FDG) PET CT was found to be a sensitive imaging test for identifying metastatic infectious foci in Gram-positive bacteremia, including SAB.
Objectives: To examine the impact of using FDG PET CT in the diagnostic algorithm of non-IE SAB compared to standard treatment recommendations on treatment duration and clinical outcomes.
Methods: A prospective interventional non-comparative cohort study conducted at Rambam Health Care Campus. Patients with SAB, defined as microbiologically and clinically, will undergo FDG PET CT 10-14 days following the first positive blood culture for diagnosis of septic extra-cardiac foci of infection. Patients with IE will be excluded. Short (2 weeks) versus long treatment (4-6 weeks) will be recommended for negative and positive PET CT tests, respectively. Patients will be followed-up for 1 year for relapse of infection and mortality.
We will document the sensitivity and specificity of PET CT for detection of complications among patients with SAB. We will examine the percentage of patients in whom the use of PET CT changed treatment duration compared to standard recommendations. We will compare also, the relapse rate and 1 year mortality rate with data from previous studies and local data. Assuming a 15% rate of management changes compared to consensus recommendations, a sample of 150 patients will achieve the required 95% CI.
Significance: Our trial will serve for improving decision making in patients with non-IE SAB, shortening treatment duration in unnecessary cases and decreasing relapse rate by giving prolonged appropriate treatment for metastatic infection not identified by standard management algorithms. PET CT is assuming an increasingly important role in infection diagnosis and management. The current study will be the first to examine the role of PET CT in directing management of patients with SAB.
详细描述
Objectives :
Since it has been shown that PET CT is a sensitive modality for detecting complications of Gram-positive bacteremia, mainly S. aureus, we sought to examine a diagnostic algorithm of SAB using PET CT. Specifically, we plan to examine:
- In patients fulfilling current criteria for a short course of antibiotic treatment for SAB, are there patients who should receive longer treatment due to the presence of undetected foci of infection on PET CT?
- In patients with risk factors mandating prolonged antibiotic treatment according to current guidelines (without IE) and a negative PET CT, is treatment discontinuation after two weeks of treatment safe?
- For patients with primary bacteremia, does a PET CT improve outcome (relapses, length of stay (LOS), survival)?
Study design:
A prospective, interventional, non-comparative cohort study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18y old with SAB, defined as at least one positive blood culture and at least two of the criteria of Systemic Inflammatory Response Syndrome (SIRS) (33):
- •a temperature of more than 38°C or less than 36°C;
- •an elevated heart rate greater than 90beats per minute;
- •tachypnea, manifested by a respiratory rate greater than 20 breaths per minute or hyperventilation, as indicated by a partial pressure of arterial carbon dioxide of less than 32 mmHg;
- •an alteration in the white blood cell count, such as a count greater than 12,000/cu mm, a count less than 4,000/cu mm; or the presence of more than 10% immature neutrophils.
- •Patients with polymicrobial bacteremia will be included, but we will mandate growth of S. aureus in at least two blood culture bottles.
排除标准
- •Pregnancy
- •Infective endocarditis
- •Patients with background survival expectation of less than 1 week.
结局指标
主要结局
Management changes triggered by PET CT (percentage of management changes triggered by PET CT will be documented per patient group)
时间窗: 1 year
次要结局
未报告次要终点