Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Nephrotoxicity in Subjects
研究概览
简要总结
Evaluate the safety and outcomes associated between the two treatment modalities
详细描述
Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
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
- •Adult patients at least 18 years of age
- •Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
- •Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
- •Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
- •Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment
排除标准
- •Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
- •Pre-existing leukopenia: White Blood Cell (WBC) < 4,000 x 103 cells/µL
研究组 & 干预措施
continuous infusions (CI) group
CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
干预措施: Vancomycin CI (Drug)
Intermittent infusion (II) group
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
干预措施: Vancomycin II (Drug)
结局指标
主要结局
Number of Nephrotoxicity in Subjects
时间窗: week 8
Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
次要结局
- Number of Leukopenia in Subjects(week 8)
- Number of Infusion-related Reactions(week 8)
- Number of Serum Vancomycin Measurements Within Therapeutic Range(week 8)
- Number of Participants With Resolutions of Symptoms Associated With the Infection(week 8)
- Number of Participants With Treatment Failures(week 21)