Effects of Daptomycin in the Levels of IL-1, IL-6 and TNF in Patients With Complicated Cellulitis/Erisipela in Comparison With Vancomycin or Oxacillin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cytokine levels
研究概览
简要总结
Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both groups according to levels of the cytokines evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will be age between 18 and 65 who required hospitalization and parenteral antimicrobial therapy
- •Clinical documentation of cellulitis / erysipela
- •Documentation of a minimal surface area 75 cm2 based on the length and / or width of the redness, swelling and / or induration
- •Documented fever, defined as oral or tympanic temperature greater than or equal to 38 ° C
排除标准
- •Infections and other minor addition of erysipelas / cellulitis
- •Any recent use of antibacterial drug therapy (systemic or topical antibacterial drugs within 14 days of enrollment)
- •Patients with clinical conditions that alter the interpretation of the primary outcome as patients with neutropenia or compromised immune function, as HIV infection, autoimmune disorders, use of corticosteroids.
- •Patients with known or suspected osteomyelitis.
- •Patients with suspected or confirmed septic arthritis.
- •Patients with complicated skin infections, such as diabetic foot infections.
- •Chronic use of antipyretic drugs (eg, daily use of naproxen).
- •Less than 18 years of age.
- •Patients with mixed infections of Gram-negative or be deleted since the therapy of gram-negative can influence the levels of cytokines.
- •Patients with renal clearance <30 mL / min.
- •Patients who are not susceptible to daptomycin or vancomycin.
- •Allergy to study medication.
研究组 & 干预措施
Daptomicina
干预措施: Daptomycin (Drug)
Vancomycin
干预措施: Vancomycin (Drug)
结局指标
主要结局
Cytokine levels
时间窗: AUC will be calculated with multiple time points over a period of 14 days (0, 4, 8, 12 , 16, 24, 48, 72, 96, 120 and 168 hours post-dose)
The results of cytokine levels will be evaluated after completion of antibiotic therapy, when testing will take place in the laboratory. Thus the measurement of cytokines will not be used to evaluate the clinical outcome.
次要结局
未报告次要终点
研究者
Felipe Francisco Bondan Tuon
PhD
Hospital Universitario Evangelico de Curitiba