A pilot study for optimizing meropenem administration in the intensive care unit – short six times vs. prolonged three times courses daily
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days
研究概览
简要总结
The main objective is to demonstrate that meropenem given as 1 g in 15 minutes infusions 6 times daily is as good as the recommended dosing 2 g given during 3 hours 3 times daily.
详细描述
The primary aim of this pilot study is to examine if the dosing of the antibiotic meropenem given as 1 gram 6 times daily in 15 minutes infusions can be compared to 2 grams given 3 times daily in 3 hours infusion when measuring the serum concentration above the minimum inhibitory concentration (MIC) ≥ 50 % of the time (2 mg/l).
The secondary aims are
- That both administration forms will result in serum concentrations above MIC ≥ 100 % of the time (2 mg/l)
- Days in hospital
- 30 days mortality after admittance to the ICU
- Serious side-effects
Five extra blood samples will be performed 24, 48 and 72 hours between two dosing intervals. The dose will be adjusted according to renal function which will be monitored daily. The patients will be supervised for adverse effects until 2 days after treatment has stopped.
The study will be performed from 2021 to the end of 2024.
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
- None
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
- •Participants must be 18 years of age at inclusion to give informed consent
- •The participant must be admitted to the Intensive Care Unit at Oslo University Hospital, Rikshospitalet
- •The participant must have a condition with confirmed or suspected serious infection
- •There is indication for treatment with meropenem for at least 3 days
- •The patient or next of kin must give informed consent to participate in the study
- •Both genders can be included in the study. Fertile women , all women in the study who are not menopausal, i.e. over 12 months since last menstruation, must use contraception or a pregnancy test must be performed.
- •If the patient is awake and mentally orientated, the patient shall be asked for consent. If the patient is not able to consent due to sedation, intubation or the like, next of kin will be asked for consent, which may be delayed until the next day.
排除标准
- •If the participant has known hypersensitivity to meropenem or some of the additives to this drug or other drugs of the betalactam group of antibiotics.
- •If the patient are also treated with valproicacid/sodiumvalproat/valpromid, the participant shal be excluded from the study as these drugs increase the treshold for seizures.
- •If a women is pregnant, she cannot be included in the study. Fertile women must use contraceptives or have a negative pregnancy test to be included. Postmenopausal women, i.e. > 12 months since last menstruation, can be included.
- •With the lack of informed consent after Day 1 after inclusion in the study, the patient cannot be included in the study.
结局指标
主要结局
Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days
Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 50% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days
次要结局
- Proportion of patients who achieve adequate meropenem concentration (>2 mg/l) > 100% of the time per day (50% T>MIC) when dosing with more frequent and shorter infusions after 1, 2 and 3 days
- Lenght of stay in the intensive care unit.
- Mortality 30 days after admission to the intensive care unit.
- Serious adverse events
研究者
Ingvild Nordøy
Scientific
Oslo University Hospital HF