Comparison Between Carbapenems and Noncarbapenem Broad Spectrum Beta-lactam Antibiotics as Initial Antibiotic Therapy Against Sepsis in Burn Patients: A Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The primary outcome is to evaluate survival rate associated with carbapenems as initial therapy for sepsis in burn patients compared with non carbapenem antibiotics by comparing SOFA score between two groups.
研究概览
简要总结
The aim of this work is to evaluate the efficacy associated with Meropenem(example of carbapenems) as initial therapy for sepsis in burn patients compared with Pipracillin/Tazobactam (example of non carbapenem beta lactam antibiotics).
详细描述
As causative pathogens are not usually identified at the time of initiating antibiotics in sepsis in burn patients, carbapenems are commonly used as an initial treatment. To reduce indiscriminate use of carbapenems, the efficacy of alternative empiric regimens, such as piperacillin-tazobactam and the fourth-generation cephalosporins, should be elucidated. The aim of this study is to compare efficacy of Meropenem and piperacillin tazobactam as an initial therapy of sepsis in burn patients .
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burned patients admitted to Burn Unit of Ain Shams university hospitals diagnosed with sepsis, not transferred from other hospitals, Age group between 21 - 60 years old, ASA I and II.
排除标准
- •Refusal of participation in the study,
- •Patient with no signs of sepsis,
- •Patients who died within 24 hours after admission,
- •Patients concomitantly received carbapenems and other broad-spectrum beta-lactams,
- •Data from the second and subsequent hospitalizations of patients who were hospitalized multiple times during the study period and used only the data from the first hospitalization,
- •Patients younger than 21 years old and older than 60 years old.
研究组 & 干预措施
Meronem group
Meronem group will receive Meronem 2 gm Iv infusion over 3 hours every 8 hours per day
干预措施: Meropenem I.V. 2g as a 3 hour infusion every 8 hours (Drug)
Tazocin group
Tazocin group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day
干预措施: Tazocin (pipercillin/tazobactam) (Drug)
结局指标
主要结局
The primary outcome is to evaluate survival rate associated with carbapenems as initial therapy for sepsis in burn patients compared with non carbapenem antibiotics by comparing SOFA score between two groups.
时间窗: 2 weeks
The primary outcome of this work is to evaluate rate of survival associated with carbapenems as initial therapy for sepsis in burn patients compared with non carbapenem antibiotics by measuring SOFA score at day 4 and day 7 of starting of treatment.
次要结局
- Occurrence rate of enterocolitis due to Clostridium difficile. (rate of patients with diarrhea and stool culture shows Clostridium difficile in each group).(2 weeks)
研究者
Ramy Mohamed Mohamed Abdelfattah
assistant lecturer of anesthesia and ICU
Ain Shams University