Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Clinical success rate at the end of treatment and/or the time transfer out of ICU
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).
详细描述
This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old.
- •Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
- •Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
- •at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
- •sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test.
- •intravenous injection of Ceftazidime Avibactam for more than 72 hours.
- •understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing.
排除标准
- •Participants are less than
- •Death within 72 hours after the start of treatment.
- •Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
- •No indication for treatment with ceftazidime avibactam.
- •Pregnant and lactating women.
结局指标
主要结局
Clinical success rate at the end of treatment and/or the time transfer out of ICU
时间窗: the end of treatment or the time transfer out of ICU,up to 1 year.
Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed.
Microbiologic success rate at the end of treatment and/or the time transfer out of ICU
时间窗: the end of treatment or the time transfer out of ICU,up to 1 year.
Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population.
次要结局
- Length of Hospital Stay (LOS)(the end of treatment or the time transfer out of ICU,up to 1 year.)
- All-cause mortality on 90 days after drug initiation(90 days from drug initiation)
- All-cause mortality on day 28 after drug initiation(28 days from drug initiation)
- Length of ICU Stay(the end of treatment or the time transfer out of ICU,up to 1 year.)
- Time from ceftazidime-avibactam treatment initiation to symptom improvement(the end of treatment or the time transfer out of ICU,up to 1 year.)
- Infection-related mortality during hospitalization in ICU(the end of treatment or the time transfer out of ICU,up to 1 year.)
- Recurrence rate of infection on day 28 after starting medication(28 days from drug initiation)
研究者
Lingai Pan
Associate Clinical Professor
Sichuan Provincial People's Hospital