Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Total antibiotic exposure days per 1,000 days
研究概览
简要总结
In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired pneumonia. Therefore, the safety of this intervention will be carefully measured.
详细描述
Methods
• Patients and settings:
All adult (> 18 years old) patients with diagnosis community-acquired pneumonia will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician.Patients will be randomly assigned to one of two groups, which respectively include PCR and PCT clinical procedure protocol. Randomization will be done using a table of random numbers generated by computer. For practical reasons the doctors treating the patients in question have science group in which the patient was included.
Patients included in the two groups will have baseline assessment during the first day of study:
- Clinical evaluation of basic
- Start of antibiotic therapy
- Inclusion in the study
- Randomization (after signing the Informed Consent)
- Interventions:
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, Care Provider)
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
- •Signed informed consent
- •Suspected or confirmed community-acquired pneumonia
排除标准
- •Nosocomial pneumonia: development of symptoms after 48 hours of admission to the Emergency Department, or within 14 days after hospital discharge
- •Patients with lung cancer confirmed strongly suspected.
- •Patients with severe immunosuppression, such as severe neutropenia (<500 neutrófilos/mm3), use of corticosteroids in doses above 0.5 mg / kg / day of prednisone or equivalent for at least 2 weeks, transplantation of solid organs or cells hematopoietic, use of immunosuppressants for any other reason (eg. azathioprine or cyclosporine), hipogamagloulinemia
- •Patients with asplenia in any order
- •Patients with known HIV infection
- •Stay indicated only for social reasons
- •Patients on antibiotics for any other reason
- •Patients with multiple trauma, burns or surgery grid size in the last 5 days
结局指标
主要结局
Total antibiotic exposure days per 1,000 days
时间窗: 28 days
Duration of antibiotic therapy for the first episode of infection
时间窗: 28 days
Days alive without antibiotics
时间窗: 28 days
次要结局
- In-hospital mortality(28 days)
- clinical cure rate(28 days)
- All cause 28-day mortality(28 days)
- Nosocomial infection rate(28 days)
- Isolation of resistant bacteria(28 days)
- costs of hospitalization(Whole hospitalization)
- Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)(28 days)
- All cause 90-day mortality(90 days)
- Length of hospitalization stay(Whole hospitalization)
- Infection relapse (diagnosed less than 48h after antibiotic discontinuation)(28 days)
研究者
Vandack Alencar Nobre
Associate Professor, PhD
Federal University of Minas Gerais