跳至主要内容
临床试验/CTRI/2025/10/096694
CTRI/2025/10/096694尚未招募不适用

An Exploratory Clinical Study to assess the role of Therapeutic Drug Monitoring of Amikacin and Vancomycin in achieving target drug levels and reducing Adverse Drug Events in Hospitalised Patients

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1. Proportion of patients who achieved their drug levels within the therapeutic range.

研究概览

简要总结

Therapeutic drug monitoring TDM plays a crucial role in drugs with narrow therapeutic indices such as aminoglycosides amikacin and glycopeptides vancomycin where small dosing changes can significantly impact efficacy or toxicity Both amikacin and vancomycin are critical narrow spectrum antibiotics frequently used in the treatment of severe infections particularly in critically ill patients However these drugs possess a narrow therapeutic index meaning that the range between an effective and a toxic dose is small For amikacin subtherapeutic dosing risks treatment failure and fosters the development of resistant Gram negative organisms while overdosing significantly increases the likelihood of nephrotoxicity and ototoxicity particularly in patients with renal dysfunction or prolonged therapy durations Similarly vancomycin underdosing may lead to persistent bacteraemia and resistance especially in Staphylococcus aureus infections while overdosing is associated with acute kidney injury AKI This is particularly problematic in the ICU where altered pharmacokinetics due to sepsis fluid shifts and organ dysfunction amplify inter individual variability As such precise dosing guided by Therapeutic Drug Monitoring TDM is essential to ensure efficacy while minimizing toxicity Hence we are planning to do TDM in critically ill patients as these patients often have altered and unpredictable pharmacokinetics due to changes in volume of distribution organ dysfunction and use of extracorporeal support Also TDM allows individualized dosing based on measured drug concentrations reducing the risk of toxicity and increasing the probability of target attainment This study outlines evidence based strategies for the implementation of TDM to maximize therapeutic efficacy while minimizing adverse effects

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted in the ICU and/or wards in whom intravenous amikacin or vancomycin therapy is initiated for proven or suspected Gram-negative (amikacin) or Gram-positive (vancomycin) infections
  • Patients or LAR willing to give consent for the study.

排除标准

  • Patients who are hemodynamically unstable in form of intubation, shock requiring ionotropes.
  • Patients who need other antibiotics for their clinical management
  • Patients not willing to give consent for the study.

结局指标

主要结局

1. Proportion of patients who achieved their drug levels within the therapeutic range.

时间窗: 3 time point (trough- before the drug, 2 peak time points)

2. Proportion of patients in whom adverse effects like nephrotoxicity were reduced

时间窗: 3 time point (trough- before the drug, 2 peak time points)

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Renuka Munshi

TN Medical College & BYL Nair Hospital

研究点 (1)

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