NCT05665478尚未招募不适用
Dose Optimization of Carbapenem Antibacterials in Febrile Neutropenia Patients Based on PPK/PD Model and MAPB Method and Research on Individualized Drug Use Software
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 100 人开始时间: 2022年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change of antipyretic time 12 days after drug administration
研究概览
简要总结
- Evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the PPK/PD model combined with MAPB method for patients with malignant hematological myelopathy accompanied by fever, as compared with the current conventional treatment regimen;
- The visualization software of meropenem individualized medication was developed with the help of JAVA development language, J2EE framework and SQL Server database.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, regardless of gender;
- •Patients with malignant hematological diseases with neutropenia and fever are judged as high-risk patients according to the Guidelines for Clinical Application of Antibiotics in Patients with Neutropenia and Fever in China (2020 Edition);
- •There is infection, and the results of drug sensitivity test show that pathogenic bacteria are sensitive to meropenem or meropenem is used according to experience;
- •The blood concentration of meropenem has reached a steady state;
- •Each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database;
- •Sign the informed consent form.
排除标准
- •Patients with non-malignant hematological diseases;
- •Non-granular deficiency with fever;
- •Those who did not reach steady state when receiving meropenem;
- •There is a history of meropenem drug allergy;
- •The patient lacks treatment compliance based on the patient's history and the judgment of the researcher;
- •The patient has hemophagocytic syndrome;
- •Patients undergoing renal replacement therapy;
- •Patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples);
- •The sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol);
- •Pregnant and lactating women;
- •Cases considered by the researcher as unsuitable for inclusion.
结局指标
主要结局
Change of antipyretic time 12 days after drug administration
时间窗: Baseline and at the first 0 hour, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours, 264 hours, 288 hours after administration,
The antipyretic time of the experimental group is compared with that of the control group. If the antipyretic time of the experimental group is shorter than that of the control group, the experimental treatment is considered effective.
次要结局
未报告次要终点
研究者
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