A Prospective, Randomized Trial Comparing Vancomycin With Trimethoprim/Sulfamethoxazole for the Treatment of MRSA Osteomyelitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
The primary question of this study is to understand if trimethoprim-sulfamethoxazole (TMP-SMX) is as effective as vancomycin for treating methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
详细描述
Treatment of osteomyelitis is hampered by a paucity of evidence from prospective clinical trials with randomized treatment arms. Furthermore, previous randomized or observational trials have enrolled small numbers of subjects and thus often had non-definitive findings. One of the most common causes of osteomyelitis is Staphylococcus aureus. Over the past 10 years, rates of methicillin-resistant S. aureus (MRSA) have risen dramatically. Vancomycin is currently the treatment of choice for treating MRSA. While vancomycin is effective, it is only available in intravenous formulation and has renal and bone marrow toxicities. There is a critical need for effective, oral, cheap drugs for the treatment of MRSA. Trimethoprim-sulfamethoxazole (TMP-SMX) is a drug with several advantageous properties for the treatment of MRSA osteomyelitis. To address this question regarding optimal treatment of MRSA osteomyelitis, we designed a prospective, randomized trial comparing TMP-SMX with vancomycin for the treatment of MRSA osteomyelitis.
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
- •Culture-proven MRSA, obtained in operating room or sterile biopsy procedure from bone site. The infection and sampling site can either be within bone or a deep soft-tissue site that is contiguous with bone; OR radiographic abnormality consistent with osteomyelitis in conjunction with a positive blood culture for MRSA.
- •Surgical debridement of infection site, as needed.
- •Subject is capable of providing written informed consent.
- •Subject is at least 18 years of age.
- •Subject capable of receiving outpatient parenteral therapy for 12 weeks.
排除标准
- •Hypersensitivity to TMP-SMX or vancomycin.
- •S. aureus resistant to TMP-SMX or vancomycin.
- •Osteomyelitis that develops directly from a chronic, open wound.
- •Polymicrobial culture(the only exception is if coagulase-negative staphylococcus is present in the culture and the clinical assessment is that it is a contaminant).
- •Subject has a positive pregnancy test at study enrollment.
- •Convicted felon currently in prison.
- •Baseline renal or hepatic insufficiency that would preclude administration of study drugs.
- •Active injection drug use without safe conditions to administer intravenous antibiotics for 3 months.
- •Anticipated use of antibiotics for greater than 14 days for an infection other than osteomyelitis.
研究组 & 干预措施
Trimethoprim-sulfamethoxazole
trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks
干预措施: trimethoprim-sulfamethoxazole (Drug)
Trimethoprim-sulfamethoxazole
trimethoprim-sulfamethoxazole, double strength, 2-3 tabs twice a day by mouth for 6-12 weeks
干预措施: vancomycin (Drug)
Vancomycin
Vancomycin, dosage to be determined by serum levels, medication provided by vein and duration 6-12 weeks
干预措施: vancomycin (Drug)
结局指标
主要结局
Clinical cure
时间窗: 12 months
No clinical or radiographic evidence of infection at 12 months
次要结局
未报告次要终点
研究者
Robert Harrington
Professor, Allergy & Infectious Diseases, Medicine
University of Washington