Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens
研究概览
简要总结
The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development of new resistance. The investigators will measure beta-lactam concentration to assess the impact of drug exposure on the bacterial resistance.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the ICU with severe pneumonia (IDSA/ATS 2016/2019): presence of signs, symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough and pulmonary infiltrate by chest radiograph)
- •Age ≥18 years
- •Positive respiratory culture (with or without an initial positive rapid identification test and/or Gram stain) for Gram-negative bacteria including, but not limited to, P. aeruginosa, K. pneumoniae, E. coli, S. marcescens, H. influenzae, Enterobacter spp., M. catarrhalis, A. baumannii, Achromobacter spp., P. mirabilis, and/or B. cepacia
- •Received within the last 72 hours or will receive meropenem, cefepime, or piperacillin/tazobactam therapy
排除标准
- •Pregnancy
- •Prisoners
- •Allergy to the beta-lactams to be administered in this study
- •On renal replacement therapy at the time of randomization
- •Baseline culture resistant to the beta-lactams in the study
- •COVID patients enrolled in other trials
研究组 & 干预措施
Continuous Antibiotic Dose Over 24 hours Arm
Subjects will be receiving a continuous dose of antibiotic prescribed by their doctor for the duration they choose.
干预措施: Cefepime, Meropenem, or Piperacillin/Tazobactam (Drug)
Intermittent Antibiotic Dose Over 30 minutes
Subjects will be receiving an intermittent dose of antibiotic prescribed by their doctor for the duration they choose.
干预措施: Cefepime, Meropenem, or Piperacillin/Tazobactam (Drug)
结局指标
主要结局
Gram-negative Bacterial Resistance Emergence Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens
时间窗: 4 weeks
Bacterial resistance is defined as new numeric increases (\>/=2 fold) in the bacterial MIC during the follow-up period compared to the baseline when starting beta-lactam therapy. MICs were collected from respiratory samples and compared from study enrollment to end of the follow-up period for at least a 2 fold increase in MIC.
次要结局
- Superinfection Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens.(4 weeks)
- Microbiologic Eradication Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks)
- Clinical Cure at Day 7 of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(7 Days)
- Mortality Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks)
- Hospital Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens.(4 weeks (may extend beyond depending on patient length of stay in hospital))
- Clinical Cure at the End of Therapy Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks)
- Percent of Time Free Drug Concentrations Remain Above the Minimum Inhibitory Concentration (%fT>MIC) in the Dosing Interval Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks)
- Intensive Care Unit (ICU) Length of Stay Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks (may extend beyond depending on patient length of stay in ICU))
- Percent of Time Free Drug Concentrations Remain Above Four Multiples of the Minimum Inhibitory Concentration (%fT>4xMIC) in the Dosing Interval Between Patients Treated With Continuous and Intermittent Infusion Beta-lactam Regimens(4 weeks)