Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- occurrence of medical cure
研究概览
简要总结
The aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU
详细描述
it is Prospective randomized controlled study on One hundred forty patients to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU, Initially, each patient will be evaluated for septic shock based on the clinical criteria. Baseline microbiologic specimens will be obtained for all recruited patients through the day of diagnosis including blood C&S. Then, empirical treatment with antibiotics according to expected source of sepsis. Patients with Gram-positive cultures sensitive to Linezolid will be randomly allocated to receive Linezolid in the continuous infusion group (Group A) or conventional intermittent infusion group (Group B) in a 1:1 ratio.
Group A: seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h).
Group B: seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min.
The treatment period will be 8-10 days in both groups but might decrease or increase based on the patients' clinical response. At the beginning of the study, simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator. Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence.
The end point of the study is occurrence of thrombocytopenia (decrease in platelet count ≥ 50% from baseline or a decrease in platelet count ≤ 100 × 103/mm3).
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)
盲法说明
. At the beginning of the study, simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator. Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence.
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 aged > 18 years old
- •diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol\L (>18 mg\dL) in the absence of hypovolemia).
- •positive culture confirming linezolid susceptibility.
排除标准
- •Patient refusal.
- •Known allergy to linezolid.
- •Pregnancy and lactation.
- •Severe hepatic failure (Child-Pugh C).
- •Thrombocytopenia (platelet count < 80,000/mm3).
- •Disseminated intravascular coagulation (DIC).
- •Hematologic disease, and concurrent use of other medications that may interact with linezolid (i.e., macrolides, serotonin modulators), or drug-associated thrombocytopenia.
研究组 & 干预措施
continuous infusion
seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg of Linezolid for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h)
干预措施: Linezolid (Drug)
intermittent infusion
seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min
干预措施: Linezolid (Drug)
结局指标
主要结局
occurrence of medical cure
时间窗: 7 days
primary outcome defined as occurrence of medical cure on day 7 following linezolid initiation. Clinical cure will be indicated as normal body temperature(36.1 C- 37.2C).
次要结局
- secondary outcomes(30 days)
研究者
Ibrahim Elsayed
principle investigator
Ain Shams University