Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of positive microbial wound cultures on admission
研究概览
简要总结
This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All aims, aged ≥18 - < 99 years old admitted to UCH Burn Center with frostbite injury
- •Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
- •Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound
排除标准
- •Pregnant patients
- •Prisoners
- •Anticipated death within 48 hours of admission
- •Inability to obtain consent from patient, legally authorized representative, or proxy
- •Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
- •Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection.
- •Aim 3: Anuria due to chronic kidney disease (CKD)
研究组 & 干预措施
Aim 1: Aloe Vera
Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.
干预措施: Aloe Vera (Other)
Aim 1: Long-Acting Silver Dressings
Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
干预措施: Long-Acting silver dressings (Device)
Aim 2: Dalbavancin
Participants will receive one 1500mg dose of Dalbavancin intravenously.
干预措施: Dalbavancin (Drug)
结局指标
主要结局
The number of positive microbial wound cultures on admission
时间窗: Admission
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 4
时间窗: Hospital Day 4
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 8
时间窗: Hospital Day 8
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 12
时间窗: Hospital Day 12
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
Number of gram positive cultures at admission
时间窗: Admission
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
The number of positive microbial wound cultures on hospital day 16
时间窗: Hospital Day 16
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
Number of gram positive cultures on hospital day 8
时间窗: Hospital Day 8
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 12
时间窗: Hospital Day 12
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 16
时间窗: Hospital Day 16
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 20
时间窗: Hospital Day 20
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 24
时间窗: Hospital Day 24
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 28
时间窗: Hospital Day 28
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 32
时间窗: Hospital Day 32
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 36
时间窗: Hospital Day 36
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 40
时间窗: Hospital Day 40
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 44
时间窗: Hospital Day 44
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 48
时间窗: Hospital Day 48
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
The number of positive microbial wound cultures on hospital day 20
时间窗: Hospital Day 20
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 24
时间窗: Hospital Day 24
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 28
时间窗: Hospital Day 28
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 32
时间窗: Hospital Day 32
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 36
时间窗: Hospital Day 36
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 40
时间窗: Hospital Day 40
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 44
时间窗: Hospital Day 44
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 48
时间窗: Hospital Day 48
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 52
时间窗: Hospital Day 52
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 56
时间窗: Hospital Day 56
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 60
时间窗: Hospital Day 60
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
Number of gram positive cultures on hospital day 4
时间窗: Hospital Day 4
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 52
时间窗: Hospital Day 52
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 56
时间窗: Hospital Day 56
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 60
时间窗: Hospital Day 60
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Change in serum concentration of dalbavancin in plasma (mcg/ml) over time
时间窗: 1, 4, 12 hours, and 1,2,3,4,6,8,10,13,16 (or date of discharge if earlier) days post dalbavancin infusion
Dalbavancin concentrations in subcutaneous tissue
时间窗: Up to 12 weeks
Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g
Change in presence of Augmented Renal Clearance
时间窗: Baseline, Up to 12 weeks
Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl \> 130mL/min.
次要结局
未报告次要终点