Clinical Evaluation of a Meropenem Dosage Strategy Based on a Population Pharmacokinetic-pharmacodynamic Model in Lower Respiratory Tract Infection Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Clinical Success Rate
研究概览
简要总结
To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.
详细描述
- Subjects:lower respiratory tract infection patients
- Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
- Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
- Second endpoint: amount of used antibiotics and bacteriological successful rate.
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
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty years and older patients hospitalized at the Peking University Third Hospital with community-acquired or hospital-acquired lower respiratory tract infection.
- •Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to study enrollment.
- •The pathogen was sensitive to meropenem.
- •Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after antibiotic therapy and pathogen was resistant to the used antibiotics.
排除标准
- •Had documented hypersensitivity to carbapenems.
- •More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract specimens.
- •Positive HIV antibody titre.
- •Had known or suspected tuberculosis or other infections caused by Gram-positive cocci, viruses or fungi at baseline.
研究组 & 干预措施
Control group
The participants in control group will accept routine meropenem therapy
干预措施: Routine meropenem therapy (Drug)
Study group
The participants in study group will accept meropenem therapy based on a PPK and PD model.
干预措施: Meropenem therapy based on a PPK and PD model (Drug)
结局指标
主要结局
Clinical Success Rate
时间窗: One week after antibiotic therapy finished.
The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy. Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy. Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy.
次要结局
- Amount of Used Antibiotics(participants will be followed for the duration of antibiotic therapy, an average of 10 days)
- Bacteriological Success Rate(At the end of meropenem therapy, an average of 10 days.)
研究者
Qingtao Zhou
Associate professor
Peking University Third Hospital