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最新改良型新药及创新药立项开发
- GLP-1
ChiCTR2400081254
正在进行
万古霉素+美罗培南
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万古霉素+美罗培南
2024-02-27
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Sepsis
萬古黴素和美羅培南的藥代動力學研究和兒科先導抗生素導向計劃
萬古黴素和美羅培南的藥代動力學研究和兒科先導抗生素導向計劃
1. To provide evidence-based recommendation for vancomycin in paediatric patients by development of a local population pharmacokinetic model using vancomycin therapeutic drug monitoring 2. To provide evidence-based recommendation for continuous-infusion meropenem in paediatric patients by development of a local population pharmacokinetic model using meropenem therapeutic drug monitoring with the aim to predict T>MIC (percentage of time that drug concentration exceeds the MIC) 3. To evaluate the implementation of paediatric antibiotic stewardship program (ASP) in paediatric patients and the impact on microbiology and clinical outcomes , including the study of vancomycin dose optimization calculator guided by Bayesian estimated PK/PD target to estimate the 24-hour AUC/MIC (24 hour area under the concentration-time curve to MIC ratio) and evaluation of its impact on microbiology and clinical outcomes, including PK/PD attainment
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Department of Microbiology/CUHK
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50;100
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2024-03-01
2027-02-28
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Inclusion criteria (Part 1): Patients in NICU and PICU and other paediatric units prescribed with intravenous vancomycin Inclusion criteria (Part 2): Patients in NICU and PICU and other paediatric units prescribed with intravenous meropenem Inclusion criteria (Part 3): Receipt of at least one of the selected antibiotics (intravenous vancomycin or intravenous meropenem) for at least 48 hours；
登录查看Exclusion criteria (Part 1): Age more than 18 years Patients with extreme prematurity (born before 28 weeks of pregnancy) Subject’s parent or guardian who is not willing to sign informed consent Exclusion criteria (Part 2): Age more than 18 years Patients with extreme prematurity (born before 28 weeks of pregnancy) Subject’s parent or guardian who is not willing to sign informed consent Exclusion criteria (Part 3) Age more than 18 years；
登录查看Department of Microbiology/CUHK
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药品研发- 全球临床试验1条
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