Ceftaroline in the Treatment of Bone and Joint Infections
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sustained clinical remission from the treated osteoarticular infection
研究概览
简要总结
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.
详细描述
Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adults > 18 years of age with the following osteoarticular infections:
- •Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.
- •Criteria for infected joint:
- •Sinus tract which communicates with the joint
- •Preoperative diagnosis by diagnostic, culture positive arthrocentesis
- •Intraoperative diagnosis-evidence of purulence/inflammation is seen by the surgeon and/or the pathologist, and at least 2 intraoperative samples grow the same organism (only 1 needed if S. aureus) OR
- •Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)
- •Onset less than 4 weeks prior to evaluation
- •Radiographic (plain, MRI, TC) evidence of osteomyelitis
- •Positive culture from bone or blood culture with organism known to cause osteomyelitis
- •Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible
- •Exclusion criteria:
- •Immunocompromised hosts:
- •AIDS/HIV patients
- •Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.
- •Any condition requiring > 20 mg prednisone or equivalent
- •TNF (tumor necrosing factor) inhibitor use (ongoing)
- •Organ transplant list
- •Diabetic foot infections
- •Osteomyelitis in association with decubitus ulcers
- •Vertebral osteomyelitis/spinal epidural abscess
- •Septic bursitis
- •Gonococcal arthritis
- •Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.
- •Infected external fixation devices
- •Calculated creatinine clearance < 50 mL/min at baseline
- •History of severe penicillin/B lactam allergy (ID to evaluate)
- •Intravenous drug use - lifetime exclusion
- •Patients with a nail puncture wound to foot
- •Patients at high risk for MDR (multidrug resistant) Gram negative organisms
- •Please note the use of antibiotic containing cement is not exclusion, as it represents standard of care in some of the infections to be studied
排除标准
- 未提供
研究组 & 干预措施
Acute Osteomyelitis - Non MRSA
For treatment of Acute osteomyelitis (< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.
干预措施: Ceftaroline (Drug)
Acute osteomyelitis MRSA isolate
For treatment of Acute osteomyelitis (< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.
干预措施: Ceftaroline (Drug)
Prosthetic joint infection
For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.
干预措施: Ceftaroline (Drug)
结局指标
主要结局
Sustained clinical remission from the treated osteoarticular infection
时间窗: 1 year after study drug completion
Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen.
次要结局
- Initial clinical success from the treated osteoarticular infection(30 days after conclusion of study antibiotic)
研究者
Mark Wallace MD
Infectious Disease Faculty Practice
Orlando Health, Inc.