CTRI/2025/02/081462已完成不适用
Evaluating effectiveness of 300 mg of Posaconazole in Immunocompromised patients: an observational study.
Bajaj Healthcare Limited2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年3月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To determine the plasma concentrations of Posaconazole 300 mg using therapeutic
研究概览
简要总结
This protocol aims to investigate the efficacy and safety of posaconazole 300 mg (Posatral 300mg) tablet across various clinical indications in immunocompromised patients. By conducting a TDM for posaconazole and evaluating the impact of routine laboratory measurements on posaconazole concentrations, we seek to provide insights that can enhance the routine clinical use of posaconazole and optimize patient care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients prescribed posaconazole 300 mg tablet and are required to undergo TDM for fungal prophylaxis or treatment in various clinical settings.
排除标准
- •Patients with contraindications to posaconazole use.
- •Patients with incomplete medical records that impede thorough analysis.
- •Non-compliant patients who fail to adhere to the prescribed treatment regimen or timing.
- •Patients prescribed posaconazole for off-label indications not approved by regulatory authorities.
结局指标
主要结局
To determine the plasma concentrations of Posaconazole 300 mg using therapeutic
时间窗: Day 1 and Day 7
drug monitoring
时间窗: Day 1 and Day 7
次要结局
- To evaluate clinical outcomes, assess safety and adverse events, and analyze the correlation between TDM parameters and laboratory markers(Day 1 and Day 7)
研究者
Dr Vijaykumar Patil
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College & CPR Hospital
研究点 (2)
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