Ambulatory Administration of Meropenem With Elastomeric Pumps and an Isothermal Pouch
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Proportion of plasma meropenem levels ≥ 4 mg/L
研究概览
简要总结
This study aims to evaluate if meropenem can be administered in outpatients as a continuous infusion using elastomeric pumps and an isothermal pouch maintaining the anti-infective solution between 10° and 15°C for improved stability.
详细描述
The Outpatient Parenteral Antibiotic Therapy (OPAT) unit of the University Hospital of Lausanne uses elastomeric pumps for continuous intravenous administration of 6 different antibiotics. This mode of administration is possible for all antibiotics with a time-dependent bactericidal effect.
Meropenem belongs to this class of antibiotics, but is not stable at room temperature in elastomeric pumps. However, this antibiotic is stable at 10°C and 15°C. The investigators have therefore developed an isothermal pouch that allows the anti-infective solution to be maintained at a temperature between 10 and 15°C over 24 hours.
This study aims to evaluate the efficacy and safety of meropenem administration using an elastomeric pump maintained at a temperature between 10° and 15°C by an isothermal pouch.
The possibility of being able to administer meropenem by elastomeric pumps would greatly facilitate the ambulatory management of patients requiring treatment with this anti-infective drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients referred to the OPAT unit for a anti-microbial treatment with meropenem
- •Age ≥ 18 years
- •Informed consent signed
排除标准
- •Patients refusing a PICC-line
- •Pregnancy or desire of a pregnancy
- •Patients considered to be not eligible for outpatient treatment by the OPAT team
结局指标
主要结局
Proportion of plasma meropenem levels ≥ 4 mg/L
时间窗: Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion
Blood will be drawn to determine meropenem plasma concentrations
次要结局
- Volume administered by elastomeric pumps(Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion)
- Allergic reactions or abnormal blood tests(Once a week through treatment completion)
- Readmission(3 months after beginning of treatment)
- Cure or stabilisation of infection(3 months after beginning of treatment)
- Meropenem concentration in elastomeric pumps(Will be determined at 24 hours, and then every 72 to 96 hours through treatment completion)
研究者
Serge de Valliere
Physician
University of Lausanne Hospitals