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临床试验/NCT01549613
NCT01549613已完成4 期

Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
104
试验地点
1
主要终点
Satisfaction of Discharge Criteria

研究概览

简要总结

This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

详细描述

Specific Aim 1: Compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ED. Patients eligible for the RDTC Cellulitis Treatment Protocol will be screened for inclusion in the study. After informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). A case report form (CRF) detailing medical history, clinical characteristics, and treatments will be completed. The patients will be evaluated for meeting RDTC discharge criteria. The following time points will be collected: 1. actual time patient meets discharge criteria based on the RDTC cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. Subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ED visit for complicated skin and skin structure infection occurred within 30 days of the initial RDTC enrollment Specific Aim 2: Compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. Patients enrolled in the study will have serial digital photographs of their primary lesion taken. The images will be processed blinded to clinical data and asynchronous to the ED stay. The change in lesion area and erythema will be calculated.

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

入选标准

  • Admitted to RDTC to the Cellulitis Protocol
  • 18 yrs old or greater
  • Able and willing to give informed consent
  • Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per minute)

排除标准

  • Antibiotics given prior to enrollment
  • Suspected necrotizing infection
  • Diabetic foot ulcer
  • Genitourinary involvement
  • Post operative infection (not including simple wound closure infection)
  • Suspected gouty or septic arthritis
  • Chronic Lymphangitis
  • Requiring routine hemodialysis
  • Patient reported allergy to Vancomycin
  • Patient reported allergy to Daptomycin
  • Participation in another investigational treatment study within 30 days prior to enrollment
  • Pregnant or breast-feeding
  • Complicated skin and skin structure infection of the face

研究组 & 干预措施

standard treatment with daptomycin

Active Comparator

Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol

干预措施: Daptomycin (Drug)

standard treatment of vancomycin

Active Comparator

Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.

干预措施: Vancomycin (Drug)

结局指标

主要结局

Satisfaction of Discharge Criteria

时间窗: Time point at which outcome measure is assessed 30 days from the date of admission.

RDTC cellulitis protocol discharge criteria

次要结局

  • Digital and Infrared Imaging(Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Shaw

Associate Professor

University of Cincinnati

研究点 (1)

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