Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
研究概览
简要总结
In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.
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
- •having an ABSSSI or a minor cutaneous abscess treated in the ED
- •age 18 years or older
- •any one or more of the following co-morbidities:
- •diagnosis of diabetes mellitus
- •obesity with a BMI >35
- •chronic kidney disease
- •coronary artery disease
- •peripheral vascular disease
排除标准
- •known history of or current thrombocytopenia
- •Currently taking anti-depression medication
- •Current or recent hospitalization
- •Known current alcohol or drug abuse
- •Known or suspected hypersensitivity to any ingredient of the study drugs
- •Irregular heart rate and blood pressure measurements
- •Fevers or low body temperature
- •Known psychiatric condition
- •Superficial skin infection
- •Skin infection caused from an animal bite
- •Recent treatment with antibacterials
- •Pregnancy
- •Other protocol related inclusion/exclusion criteria may apply.
结局指标
主要结局
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
时间窗: 40 days after completion of treatment
Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.
次要结局
- Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days(7 days after completion of treatment)
- Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days(40 days after completion of treatment)
- The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment(40 days after completion of treatment)