2024-517888-23-00招募中3 期
Model-informed precision dosing for linezolid: a randomized clinical trial
University Medical Center Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary endpoint is defined as the achievement of a trough linezolid concentration within the range of 2 to 8 mg/L on Day 7, where concentrations within this range will be considered a success, and concentrations below 2 mg/L or above 8 mg/L will be considered a failure. Also, patients for whom a TDM sample is not obtained on Day 7 will be considered as failures.
研究概览
简要总结
To determine whether model-informed precision dosing optimizes linezolid dosing in order to better achieve a therapeutic trough concentration compared to standard dosing.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult trial participants a) ≥ 18 years of age b) Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each
- •Participation a) with written informed consent of the patient or, Alternatively, but only if the patient is temporarily incapable of giving informed consent b) with written informed consent of his/her legally designated representative or c) after using the option of inclusion via spouse according to § 1358 BGB or d) according to article 35 of the CTR and with obtaining the patients informed consent as soon as possible
- •Patients with potential childbearing ability: negative pregnancy test
排除标准
- •Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis
- •Concomitant treatment with monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, tranylcypromine, moclobemide or selegiline)
- •Patients whose life expectancy is less than 7 days
- •Lactation/breastfeeding
- •Previous participation in this study
- •Simultaneous participation or participation in the past 4 weeks in another clinical trial with other medicinal products
研究组 & 干预措施
LINEZOLID
Test
干预措施: LINEZOLID (Drug)
结局指标
主要结局
The primary endpoint is defined as the achievement of a trough linezolid concentration within the range of 2 to 8 mg/L on Day 7, where concentrations within this range will be considered a success, and concentrations below 2 mg/L or above 8 mg/L will be considered a failure. Also, patients for whom a TDM sample is not obtained on Day 7 will be considered as failures.
The primary endpoint is defined as the achievement of a trough linezolid concentration within the range of 2 to 8 mg/L on Day 7, where concentrations within this range will be considered a success, and concentrations below 2 mg/L or above 8 mg/L will be considered a failure. Also, patients for whom a TDM sample is not obtained on Day 7 will be considered as failures.
次要结局
- Toxicity: - proportion of patients with peripheral neuropathy among both groups
- -Median length of hospital stays since the first linezolid infusion up to EOF
- -all cause ICU mortality up to EOF (respectively for the modified Intention-to-treat (mITT) population and all randomized patients)
- -all cause hospital mortality up to EOF (respectively for the mITT population and all randomized patients)
- -Incidence of SAEs
- Likelihood of maintaining a trough linezolid concentration between 2 to 8 mg/L on Day 13
- Pharmacokinetic: -Investigation of differences in the occurrence of certain AES (elevated lactate (> 2 mmol/L), thrombocytopenia (<150/µL))
- Toxicity: - comparison between the mean of platelets count among both groups (for each day) after the start up to end of linezolid treatment for the control group and after the first adapted dose by TDMx up to the end of linezolid treatment for the intervention group
- Toxicity: - comparison between the mean of lactates among both groups (for each day) after the start up to end of linezolid treatment for the control group and after the first adapted dose by TDMx up to the end of linezolid treatment for the intervention group
- Microbiological: - proportion of patients with rectal/nasal/inguinal carriage of gram-positive bacteria resistant to linezolid among both groups acquired from the Baseline and the EOT up to EOF
- Microbiological: - proportion of patients achieving microbiological eradication (sterilization of blood cultures or the biological material previously infected) of gram-positive bacteria identified at the beginning of linezolid treatment among both groups, if applicable
- Microbiological: - proportion of relapse (growth of the same gram-positive organism in the blood culture or in another primarily site infected up to EOF after microbiological eradication) episode among the two groups
- -Comparison of mean Overall duration of linezolid infusion among two arms
- -Median length of ICU stays since the first linezolid infusion up to EOF
研究者
Prof. Dr. med. Dominic Wichmann
Scientific
University Medical Center Hamburg-Eppendorf
研究点 (1)
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