The Use of a Procalcitonin (PCT)-Guided Protocol to Shorten the Duration of Antibiotic Therapy in Febrile Neutropenic Patients. An Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure
研究概览
简要总结
In this study the investigators aim to test if a procalcitonin (PCT) - guided strategy allows to reduce the antibiotic use in patients with febrile neutropenia hospitalized in a Brazilian tertiary university hospital, causing no harm.
详细描述
Methods
- Patients and setting: Prospective controlled randomized interventional study of antibiotic therapy in adult with febrile neutropenia.
The study will be conducted in the University Hospital of the Federal University of Minas Gerais, Brazil. This is a 600-bed tertiary hospital, with approximately 1.6 thousands hospitalizations/month. Roughly 120 episodes of febrile neutropenia were recorded in the first semester of 2007, occurring in 100 patients with hematological leucosis or post-BMT. This number rises if one considers other groups of neutropenic patients, such as those with neutropenia due chemotherapy for solid tumors, patients with BM aplasia, myelo dysplasia, among others,
- Interventions:
As long as the core objective of the study is to test if a PCT-guided protocol allows to guide the antibiotic withdrawn in neutropenic patients, only patients with febrile neutropenia under antibiotic therapy will be included in the study. They will be submitted to the following exams:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •febrile neutropenia
- •to be under antibiotic therapy
- •signed informed consent
排除标准
- •patients under antibiotic therapy for more than 72 hours before inclusion
- •patients post allogenic bone-marrow transplant (BMT)
- •patients presenting one or more of the following conditions at the time of randomization:
- •severe mucositis
- •all-trans retinoic acid (ATRA) syndrome
- •disseminated intravascular coagulation
- •hypotension (systolic blood pressure < 90 mmHg or need for vasopressor to maintain blood pressure)
- •respiratory failure (arterial oxygen pressure < 60 mmHg while breathing room air) or need for mechanical ventilation
- •severe renal failure requiring hemodialysis
- •patients with suspected (positive galactomannan assay in peripheral blood, nodular lesions with halo in the chest CT) or microbiologically confirmed fungal infection
- •bacteremia due to S. aureus
- •microbiologically confirmed carbapenem resistant P. aeruginosa or A. baumanii infection
- •microbiologically confirmed pneumonia due to P. aeruginosa, A. baumanii or Stenotrophomonas maltophilla
- •suspected or confirmed infection caused by atypical microorganisms (virus, parasites, P. jiroveci). Patients with localized HSV infection (e.g., labial) will be accepted for inclusion
- •infections requiring prolonged therapies, such as endocarditis and cerebral abscess
- •clearly focal bacterial infections
研究组 & 干预措施
Group 1 - PCT group
interventions on antibiotic therapy will be based on circulating PCT levels
干预措施: procalcitonin (Other)
Group 1 - PCT group
interventions on antibiotic therapy will be based on circulating PCT levels
干预措施: antibiotic therapy (Drug)
Group 2 - Control group
antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.
干预措施: procalcitonin (Other)
Group 2 - Control group
antibiotic therapy will be guided by appropriate guidelines, and will be left at the discretion of caregivers.
干预措施: antibiotic therapy (Drug)
结局指标
主要结局
Antibiotic exposure, measured by: - incidence density of ''antibiotic exposure days'' - incidence rate ratio (IRR) of antibiotic exposure
时间窗: 28 days
Number of days alive without antibiotics
时间窗: 28 days
Duration of antibiotic therapy for the first episode of fever
时间窗: 28 days
次要结局
- Length of hospital stay(6 m)
- All cause and infection-related 28-day mortality(28 days)
- All cause 90-day mortality(90 days)
- Clinical cure rate(28 days)
- Nosocomial superinfection (diagnosed more than 48 hours after discontinuation of the antibiotic(s) given to the first episode of infection)(28 days)
- Infection relapse (diagnosed less than 48 h after antibiotic discontinuation)(48 hours)