A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- Infection-Related Hospital Length of Stay
研究概览
简要总结
This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.
详细描述
Eligible participants will be recruited within 24 hours of hospital admission for cSSSI due to suspected or documented Methicillin-resistant Staphylococcus Aureus (MRSA), and who are anticipated to require IV antibiotics effective against MRSA and at least 3 days of hospitalization for management of cSSSI. The primary objective is to compare infection-related hospital length of stay between participants treated with daptomycin and vancomycin. Secondary objectives were to compare participant reported outcomes (pain symptoms and Health Related Quality of Life), 30 day cSSSI-related hospital readmission rates, and cSSSI-related medical resource utilization and costs between participants treated with daptomycin and vancomycin.
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
- •≥18 years of age
- •Primary reason for hospitalization is skin and skin structure infection of a complicated nature (for example, cellulitis/erysipelas, major cutaneous abscess, or wound infection) that requires IV antibiotic treatment for an anticipated 3 to14 days and hospitalization for management
- •Further defined as infections either involving deeper soft tissue or requiring significant surgical intervention or infections in which the participant has a significant underlying disease state that complicates the response to treatment
- •Are suspected or documented to be caused by MRSA
- •At least 3 of the following clinical signs and symptoms associated with the cSSSI:
- •i. Pain; tenderness to palpation; ii. Elevated temperature (>37.5°Celsius [99.5° Farenheit] oral or >38° Celsius [100.2° Farenheit] rectal); iii. Elevated white blood count (WBC) >10,000/millimeters cubed (mm^3); iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge
- •Physician determination that vancomycin or daptomycin would be the initial treatment of choice for the cSSSI under study (or meets institutional criteria for use of vancomycin or daptomycin)
- •Informed consent obtained and signed
- •Less than 24 hours post hospital admission
排除标准
- •Participants with known bacteremia, osteomyelitis, septic arthritis, or endocarditis
- •Conditions where surgery (in and of itself) constitutes curative treatment of the infection (for example, amputation, incision and drainage)
- •cSSSIs which can be managed with an oral antibiotic
- •Participants where hospitalization is expected to be <48 hours
- •Nosocomial infection
- •Participants with necrotizing infections or concomitant gangrene
- •Use of systemic antibacterial therapy for the infection for > 24 hours within 48 hours prior to the start of study drug unless (a) the infecting Gram-positive pathogen was resistant in vitro to the therapy or (b) the therapy was administered for 3 or more days with either worsening or no improvement in the infection
- •Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin
- •Participants with neutropenia or compromised immune function (that is, severe neutropenia [absolute neutrophil count <500 cells per microliter (μL)] or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy)
- •Renal insufficiency (calculated creatinine clearance [CLcr] <30 milliliters per minute or on dialysis)
- •Known to be allergic or intolerant to daptomycin or vancomycin
- •Pregnant or nursing mothers
- •Suspected implanted device or prosthetic as source of infection
- •Is considered unlikely to comply with study procedures or to be available for follow-up contact
研究组 & 干预措施
Daptomycin
4 milligrams per kilogram (mg/kg) daptomycin administered intravenously (IV) once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
干预措施: Daptomycin (Drug)
Vancomycin
Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion
干预措施: Vancomycin (Drug)
结局指标
主要结局
Infection-Related Hospital Length of Stay
时间窗: Baseline (Day 0) through the End of Hospital Stay (up to Day 14)
Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.
次要结局
- Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)(Baseline (Day 0), End of Hospital Stay (up to Day 14))
- Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)(Baseline (Day 0), End of Hospital Stay (up to Day 14))
- Participant Global Impression of Improvement (PGI-I) at Hospital Discharge(End of Hospital Stay (up to Day 14))
- 30-day cSSSI-related Hospital Readmission Rates(End of Hospital Stay (up to Day 14) through 30 days post hospital discharge)
- cSSSI-related Medical Resource Utilization and Costs(Baseline (Day 0) through 30 days post hospital discharge)