Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot.
研究概览
简要总结
This prospective clinical study will investigate if antibiotic concentrations in patients with severe infections can be monitored by the UV-VIS spectroscopy.
详细描述
Early and correct antibiotic treatment has a fundamental effect on survival in severe infections, and to prevent resistance development. However, it is unclear if this is achieved in severely ill patients with severe infections. Underdosing of antibiotics leads to lack of effect against bacteria and selection of multi-resistant strains. Overdosing of antibiotics increases the risk of toxicity and poses a threat to the environment. Currently there is no method for rapid or bedside determination of antibiotic concentration in routine health care.
Pharmacolog AB, an Uppsala Med-tech company, has developed a technology and a product DrugLog® based on absorption spectroscopy in ultraviolet - visible (UV-VIS) frequencies that can measure the concentration of antibiotics.
The goal of this project is to investigate if antibiotic concentrations in patients could be monitored by the UV-VIS spectroscopy.
In a prospective observational study, blood samples from 100 patients with severe infections treated with cefotaxime, piperacillin/tazobactam or meropenem will be measured by UV-VIS spectroscopy as well as with the golden standard, High-performance liquid chromatography-mass spectrometry (HPLC-MS) at Klinisk farmakologi, Huddinge hospital, Stockholm.
After informed consent, samples will be taken prior to antibiotic treatment and three times thereafter. Demographic and clinical data will be registered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •More than 18 years old
- •Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed
排除标准
- •Pregnancy
- •Intermittent haemodialysis
- •Patient with limited treatment decision
结局指标
主要结局
Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot.
时间窗: 0-48 hours of antibiotic treatment.
The antibiotic concentration will be calculated from the change in from transmittance measured with UV-VIS spectroscopy technique and compared with change antibiotic concentration measured with HPLC-MS using linear regression and Bland-Altman plots. The endpoint will be presented as bias (limits of agreement).
次要结局
- Agreement in antibiotic concentration change in blood after antibiotic administration with UV-VIS technique vs HPLC-MS(Blood samples will be taken just before the first dose of antibiotic, two hours after the first dose of antibiotic, just before the second dose and two hours after the second dose.)