Impact of Computerized Decision Support for ANTIBIOtic Prescription in Cancer Patients With Febrile NEutropenia in the Emergency Department on Treatment Failure. A Randomized Cluster-controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 540
- 主要终点
- Treatment failure
研究概览
简要总结
Treatment of patients with febrile neutropenia (FN) attending Emergency Departments (EDs) relies on rapid antibiotic initiation in order to control a presumed infection. The choice of initial antibiotics is empirical and depends on patient's prior colonization or infection by multi-drug resistant pathogens (MDRPs) and risk stratification. Stratification of high-risk patients needing broad-spectrum antibiotics is debated. Thus, for non-specialist physicians, this choice may be challenging, leading to inappropriate initial antimicrobial regimens, potential risks for the patient and higher costs. Furthermore, international guidelines recommended to develop antibiotic stewardship programs and promoted an initial strategy based on escalation or de-escalation approaches, with early reassessment depending on patients' clinical course and microbiological results. Nevertheless, this interesting strategy may increase the level of complexity for the choice of the initial antibiotic regimen by non-specialist emergency physicians who are often the first prescribers in this context.
We developed an interactive computerized decision support app (CDSA) for initial antibiotic prescription and early revaluation in patients with FN. The first goal of this app is to assist non-specialized physicians in choosing initial antimicrobial regimen for patients with FN when they attend EDs. It uses an interactive algorithm based on international guidelines that takes into account patients' medical history and characteristics. Secondly, the app is also designed to propose an algorithm of antibiotic revaluation at day 3-4 for hospitalized patients, depending on patient clinical course, and biological and microbiological results. The revaluation suggests antimicrobial modification (escalation or de-escalation) or discontinuation and stopping rules with recommended duration of therapy also based on international guidelines.
We hypothesize that such a CDSA may improve the adherence to guidelines for the choice of initial antibiotic regimen for FN in the ED, favour early antibiotic reassessment for hospitalized patients, both decreasing the risk of treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •age ≥ 18 years;
- •reported or observed fever at arrival at the ED (≥38.3° C on one occasion or ≥38°C on two or more occasions within 1 h);
- •chemotherapy-induced neutropenia (absolute neutrophil count ≤500/mm3 or ≤1000/mm3 and anticipated to decrease to fewer than 500/mm3 within 24 to 48 h).
排除标准
- •refusal to participate;
- •prior inclusion in the study for a previous episode of FN;
- •any intravenous antibiotic administration during the preceding 72 h;
- •renal failure requiring renal replacement therapy or with an estimated creatinine clearance of less than 20 ml/min;
- •palliative status with life expectancy of less than three days;
- •pregnancy, absence of health insurance, mental deficiency or inability to understand informed consent, no French speaking;
- •patient with a microbiological documented infection when arriving at the ED (e.g. positive blood culture).
研究组 & 干预措施
Control Group
As routine care, the choice of the initial antibiotic regimen will be let to the discretion of the emergency physician.
干预措施: routine care (Other)
computerized decision support app (CDSA) Group
干预措施: Computerized Decision support app (CDSA) (Other)
结局指标
主要结局
Treatment failure
时间窗: 7 days following inclusion
Treatment failure will be defined by any escalation of the assigned empirical initial antibiotic treatment (e.g. adjunction of aminoglycoside, glycopeptide or other anti-gram positive or any broadening of the beta-lactam spectrum) during the 7 days following inclusion, in relation with at least one of the following reasons: * microbiologic reason; * clinical progression of the presumed infection defined as persistence, recurrence or worsening of clinical signs or symptoms of presenting infection (e.g. death due to the initial infection, occurrence of sepsis or septic shock, need for oxygen therapy (or increasing oxygen flow) or mechanical or non-invasive ventilation in case of pneumonia, neurological deterioration in case of central nervous system infection). Treatment failure outcome will be reviewed by at least 2 experts blinded to the arm.
次要结局
- Number of antimicrobial spectrum reductions(at 3 days)
- Total 3-month costs(at 3 months)
- Number of days of Carbapenems, aminoglycosides and glycopeptides therapy(up to 3 months)
- Number of super-infections(up to 3 months)
- Number of super-infections due to clostridium difficile(up to 3 months)
- Number of initial antibiotic regimen adhering to the international guidelines(at inclusion)
- Time to antibiotic initiation from patient triage at the emergency department (minutes)(at inclusion)
- Number of revaluations of initial antibiotic regimen at day 3 depending on patient clinical course and microbiological results;(at 3 days)
- Number of antibiotic regimens with carbapenems, aminoglycosides or glycopeptides(at inclusion)
- Number of colonization(up to 3 months)
- Number of episodes of nephrotoxicity(up to 3 months)
- Number of episodes of other toxicities(up to 3 months)
- Occurrence of any complication during hospital stay or follow-up(up to 3 months)
- Number of re-hospitalizations due to a complication related to the initial infection(within 7 days of discharge)
- Antibiotic treatment duration(up to 3 months)
- Length of hospital stay(up to 3 months)
- Number of deaths related to infection(at 3 months)
- Number of in-hospital death(up to 3 months)
- Survival status(at day 90)
- Health related quality of life(at inclusion)
- Health related quality of life.(at 3 months)
- Health related quality of life.(at day 30)