Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: an Open Randomized Controlled Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Rate of adherence to the sampling protocol
研究概览
简要总结
This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years and older)
- •Patients hospitalized at Hôpital Charles-Le Moyne
- •Obesity (as defined by a body mass index of ≥ 30 kg/m^2)
- •Piperacillin-tazobactam prescription initiated within last 24 hours
- •Planned duration of piperacillin-tazobactam of 24 hours or more
排除标准
- •Documented allergy to beta-lactams of the penicillin class
- •Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
- •Pregnancy
- •History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
- •Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization
研究组 & 干预措施
Piperacillin-tazobactam administered in a prolonged infusion
Piperacillin-tazobactam dose will be administered over 3 hours for piperacillin-tazobactam dosages every 6 hours or over 4 hours for piperacillin-tazobactam dosages every 8 hours.
干预措施: Piperacillin-tazobactam administered in a prolonged infusion (Drug)
Piperacillin-tazobactam administered in a standard infusion
Piperacillin-tazobactam dose will be administered over 30 minutes for every piperacilline-tazobactam administered in the study (as instructed by the drug's monograph)
干预措施: Piperacillin-tazobactam administered in a standard infusion (Drug)
结局指标
主要结局
Rate of adherence to the sampling protocol
时间窗: At 24 hours of treatment of piperacillin-tazobactam after randomization
Rate of patients whose blood collection takes place 24 hours after the start of administration of piperacillin-tazobactam according to the method of administration assigned during randomization
Recruitment rate
时间窗: At the randomization
Proportion of patients meeting the eligibility criteria who consent to the study.
Achievement of a prespecified number of patients recruited per month
时间窗: At the randomization
Achievement of a number of patients recruited per month of 5 to 8 patients
Proportion of eligible patients relative to the total population who received a piperacillin-tazobactam for the study period
时间窗: From the screening period to the enrollment, assessed up to 24 hours after the start of a piperacillin-tazobactam prescription
Proportion of eligible patients relative to the total population who received a piperacilline-tazobactam for the study period
次要结局
- Proportion of patients reaching the target of fT>MIC equal to 100% after 24 hours of piperacillin-tazobactam according to the assigned intervention(At 24 hours of treatment of piperacillin-tazobactam after randomization)
- Number of days of piperacillin-tazobactam treatment under study(From enrollment to the last dose of the intervention, assessed up to 42 days)
- Need of escalation to carbapenems antibiotics(From enrollment to the last dose of the intervention, assessed up to 42 days)
- Incidence of adverse events attributed to the intervention(From enrollment to the last dose of the intervention, assessed up to 42 days)
- Number of days until de-escalation to a narrower spectrum injectable antibiotic or to an oral switch(From enrollment to the last dose of the intervention, assessed up to 42 days)
研究者
Benoit Crevier
Principal Investigator
CR-CSSS Champlain-Charles-Le Moyne