A Phase 4, Prospective, Randomized, Open-label Study to Compare Use of Cubicin With Vancomycin Administered Intravenously in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Confirmed Gram-positive Bacteria in a Home Infusion Setting
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
研究概览
简要总结
This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.
详细描述
This is a randomized, open-label, multi-center, phase 4 study. The overall goals of this study are to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of cSSSI due to Gram-positive bacteria in participants who are prescribed vancomycin for 7-14 days and who are planning to receive vancomycin in a home infusion setting. Study objectives include evaluation of clinical and resource utilization endpoints and economic analysis from the perspective of the home infusion provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Complicated skin or skin structure infection (cSSSI)
- •Intravenous vancomycin home infusion ordered for 7-14 days
排除标准
- •Pregnant or lactating female
- •Concurrently receiving other systemic antibiotics with gram positive activity
- •Known or suspected allergy or hypersensitivity to daptomycin or vancomycin
- •Known or suspected vancomycin-resistant enterococci (VRE)
- •Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
- •Known or suspected human immunodeficiency virus (HIV), cancer, or autoimmune disease such as lupus
- •Receiving systemic concomitant immunosuppressive agents such as chemotherapy, corticosteroids, tacrolimus, sirolimus, or cyclosporine, during the duration of the study
- •Requirement for non-study gram positive systemic antibiotics
- •Known to be allergic or intolerant to intravenous vancomycin or daptomycin
- •Participants with known or suspected creatinine clearance (CLcr) < 30 milliliters per minute (mL/min)
- •In skilled nursing facility
- •In hospice or admission to hospice is planned
研究组 & 干预措施
Daptomycin
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
干预措施: Daptomycin (Drug)
Vancomycin
Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician
干预措施: Vancomycin (Drug)
结局指标
主要结局
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
时间窗: Day 1 up to Day 14
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
时间窗: Day 1 up to Day 14
Reasons for Nurse Visits During Home Infusion Therapy
时间窗: Day 1 up to Day 14
The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.
Reasons for Pharmacist Consultations During Home Infusion Therapy
时间窗: Day 1 up to Day 14
The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.
Percentage of Treatment Goals Met at End of Therapy
时间窗: Day 1 up to Day 14
Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic. Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm.
Time Spent (Minutes) for Home Infusion Therapy
时间窗: Day 1 up to Day 14
Each participant is counted once per category. Avg=average; Admin=administer.
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
时间窗: Day 1 up to Day 14
Each participant is counted once per category.
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
时间窗: Day 1 up to Day 14
The mean duration in home-infusion antibiotic therapy per participant is presented.
次要结局
- Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy(Day 1 up to Day 14)
- Mean Number of Interventions Per Participant During Home Infusion Therapy(Day 1 up to Day 14)
- Number of Intervention Types During Home Infusion Therapy(Day 1 up to Day 14)
- Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy(Day 1 up to Day 14)
- Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy(Day 1 up to Day 14)
- Number of Laboratory Assessment Types During Home Infusion Therapy(Day 1 up to Day 14)
- Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant(Day 1 up to Day 14)