A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
研究概览
简要总结
This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).
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 or older with at least one blood culture positive for S. aureus within 48 hours before randomization
- •At least one of the following signs or symptoms of bacteremia:
- •Temperature ≥ 38.0°C
- •White blood cell (WBC) count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands)
- •Tachycardia (heart rate > 90 bpm)
- •Tachypnea (respiratory rate > 20 breaths/min)
- •Hypotension (systolic blood pressure < 90 mmHg)
- •Signs or symptoms of localized catheter-related infection
- •At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.
排除标准
- •Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
- •Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
- •Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)
- •Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted
- •Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
- •Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens
研究组 & 干预措施
Telavancin
7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
干预措施: Telavancin (Drug)
Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
干预措施: Vancomycin (Drug)
Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
干预措施: Daptomycin (Drug)
Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
干预措施: Synthetic penicillin (Drug)
Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
干预措施: Cefazolin (Drug)
结局指标
主要结局
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
时间窗: Up to 8 weeks
The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC). 1. Alive at TOC 2. Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC 3. No evidence of microbiological persistence of relapse 4. No new foci of metastatic S. aureus infection after Day 8
次要结局
- Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population(Up to 8 weeks)
- Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population(Up to 8 weeks)
- Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations(Day 8)