Comparative Study Between Incidence of Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Patients With Impaired Renal Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The relationship between kidney function and the development of linezolidinduced thrombocytopenia
研究概览
简要总结
Linezolid exhibits a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The major adverse effect associated with linezolid treatment is reversible myelosuppression, mostly thrombocytopenia. Recent studies have reported that the incidence of linezolid-induced thrombocytopenia was higher among patients with renal failure than in patients with normal renal function, although the underlying mechanisms explaining this toxicity are still unknown.
详细描述
Linezolid is an oxazolidinone antibiotic with the availability of intravenous and oral formulations. The latter has nearly 100% bioavailability and is expected to facilitate the treatment of infections caused by these organisms (Gram-positive bacteria).
In addition, linezolid has very favorable rates of penetration into tissues. This suggests a potential pharmacokinetic advantage of linezolid over glycopeptides in the treatment of deep-seated infections such as pneumonia and CNS infections.
Prolonged use of linezolid can lead to hematological side effects, particularly thrombocytopenia. Indeed, several studies have reported that the incidence of thrombocytopenia associated with linezolid therapy is much higher (7.5%-64.7%) than the incidence reported in an early clinical study (2.4%) conducted by the manufacturer.
Thrombocytopenia is a common complication in the intensive care unit (ICU), and its incidence ranges from 13 to 60 %.
Thrombocytopenia is defined as a platelet count of less than 100,000/μl or a decrease of at least 50 % from baseline. Thrombocytopenia can be characterized as mild (≥ 50,000/μl), moderate (30,000/μl to 50,000/μl) and severe (< 30,000/μl).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with sepsis having 2 or more of the following criteria:
- •Septic shock clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater.
- •Serum lactate level greater than 2 mmol\L.
- •Positive culture confirming bacterial infection.
- •Patients highly susceptible to infection by Gram-positive bacteria such as Nosocomial pneumonia, Community-acquired pneumonia, Complicated skin and soft tissue infections.
排除标准
- •Patient or their legal guardian refuses to include their data in the study.
- •Known allergy to linezolid.
- •Pregnancy and lactation.
- •Severe hepatic failure (Child-Pugh C as INR>2.3, Bilirubin>3mg/dl, Albumin<2.8gm/dl).
- •Thrombocytopenia (platelet count < 80,000/mm3).
- •Disseminated intravascular coagulation (DIC) as Fibrinogen<1g/L, PT more than 6 seconds increase above normal, high D Dimer level.
研究组 & 干预措施
Group N (will be with normal renal function)
干预措施: Linezolid (LZD) (Drug)
Group I (will be with impaired renal function)
干预措施: Linezolid (LZD) (Drug)
结局指标
主要结局
The relationship between kidney function and the development of linezolidinduced thrombocytopenia
时间窗: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.
次要结局
- The duration of hospital stay or ICU stay or The incidence of the need for renal replacement therapy (RRT) during hospital stay.(Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.)