Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Bloodstream Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Clinical Response Rate
研究概览
简要总结
Primary Objective:
Evaluate the efficacy and safety of daptomycin given for treatment of catheter-related bloodstream infections due to S. aureus bacteria with or without exchange of the central venous catheter (CVC) over guide wire in comparison with a historical control group of catheter-related S. aureus bacteremia treated with standard therapy (Vancomycin) or other active agents against staph aureus (such as beta-lactam antibiotics).
详细描述
Daptomycin is a new antibiotic. It may be effective against a variety of bacterial infections that are difficult to treat.
Aztreonam, Cefepime, Carbapenems and Augmentin are antibiotics that are used to treat certain types of bacteria.
If you are found to be eligible to take part in this study, you will be given daptomycin by vein for at least 10 days, depending on your certain type of bacteria. You will receive Daptomycin by vein for 30 minutes every 24 hours.
The CVC associated with CRBSI (catheter-related bloodstream infection = CR-BSI) from all enrolled patients will either be removed or be exchanged over guide wire for a new CVC within 96 hours of onset of the first blood culture. Your primary doctor will decide whether to remove or exchange the CVC with the willingness of you.
If the study doctor and/or your primary physician knows or thinks that you have a mixed infection (both "gram positive" and "gram negative") or may have infection in lungs (pneumonia), you may also be treated with the antibiotic drugs Aztreonam, Cefepime, Carbapenems, or Augmentin by vein or by mouth in combination with the study drug Daptomycin.
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
- •Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
- •The suspected culprit on exchangeable central venous catheter (CVC) is tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular or femoral vein.
- •Patients must have at least two signs of sepsis from the list below, in any combination, within 48 hours prior to Daptomycin therapy and no other source for the bacteremia other than CVC: (a) Core temperature =/>38.0 degrees C or =/<36.0 degrees C, measured orally, rectally, tympanically or via a central catheter. If axillary add 0.5 degrees C to the measured temperature; (b) Pulse rate =/> 100 beats/min.; (c) Respiratory rate =/> 20/min; (d) white blood count (WBC) count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; (e) Systolic blood pressure=/ <90 mm Hg
- •Patients with suspected or definite diagnosis of uncomplicated CVC-related gram-positive bacteremia that includes at least one positive blood culture for S aureus. (If the positive blood culture is drawn through the CVC, then at least >15 colonies/ml will be required or the differential time of positive (DTP) of CVC at least 2 hours earlier than the peripheral culture)
- •Signed informed consent
- •No apparent source for the clinical manifestation of bacteremia other than the catheter
排除标准
- •Creatinine clearance <30 mL/min at the time gram positive bacteremia was diagnosed unless the patient is on dialysis
- •Bilirubin >4 times the upper limit of normal at the time gram positive bacteremia was diagnosed
- •Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 48 hours within 72 hours of study medication initiation, unless treatment failed.
- •Documented S. aureus bacteremia within last 3 months due to source other than CVC.
- •Patients who have participated in another investigational anti-infective study within 30 days
- •History of hypersensitivity to lipopeptides
- •Presence of additional source of infection with same organism cultured from blood, eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic thrombosis
- •Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis, nephritic syndrome, end-stage renal disease
- •Anticipated prolonged therapy >4 weeks
- •Prosthetic endovascular material
- •Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.
- •Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditis, and septic thrombosis.)
- •Evidence of catheter site purulence as evidenced by purulent discharge.
- •Patients with diagnosis of pneumonia that is related to S. aureus organism
- •Patients taking concomitant "statins" (HMG-CoA reductase inhibitors)
- •creatine phosphokinase (CPK) >10 times max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.
研究组 & 干预措施
Daptomycin
6mg/kg/day intravenous (IV) for 10 days
干预措施: Daptomycin (Drug)
结局指标
主要结局
Clinical Response Rate
时间窗: 7 weeks
Clinical response of Daptomycin administered for treatment of catheter-related bloodstream infections due to Staphylococcus Aureus bacteria, evaluated within 7 weeks of initiating Daptomycin therapy.
次要结局
未报告次要终点