Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety of the antibiotic course duration
研究概览
简要总结
Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate of in-hospital complications and despite advances in critical care, wound care, and early intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. Although one of the tenets of management for NSTI is early broad-spectrum intravenous antibiotics (listed above), the duration of antibiotics needed is not well defined. Currently, there exists wide variation in the duration of antibiotics for NSTI ranging between 2-16 days. The objective of this study is to evaluate the safety of a shorter course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after source-control is achieved will have similar risk of morbidity and mortality compared to a 7-day course of antibiotics post source control. A second aim of this study will be to identify if serum procalcitonin levels/ratio correspond to resolution of systemic infection in patients with NSTI.
详细描述
The objective of this study is to evaluate the safety of a shorter course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after source-control is achieved will have similar risk of morbidity and mortality compared to a 7-day course of antibiotics post source control. The proposed shortened duration is considered within standard of care as the IDSA suggests 48-72 hours of antibiotics after source control, however this was due mostly to expert opinion until a recent single-center study using historical controls demonstrated a 48-hour duration of antibiotics to be safe. A second aim of this study will be to identify if serum procalcitonin levels/ratio correspond to resolution of systemic infection in patients with NSTI. This pilot study may help limit use of antibiotics which are associated with both cost and significant adverse events including antimicrobial resistance and clostridium difficile infections. In addition, the data would support grant submission of a larger, multi-center study with sufficient power to demonstrate the safety profile and potential benefits of a shorter duration of antibiotics, which has been shown to be beneficial in previous large surgical infection studies.
Specific Aims:
Aim#1: Establish the safety of an abbreviated course (48 hours after source control) compared to a prolonged (7 days after source control) course of antibiotics in terms of in-hospital mortality.
Aim#2: Compare the incidence of hospital length of stay and in-hospital complications including unplanned return to the operating room, ventilator days, and antibiotic associated complications (e.g., clostridium difficile infection) in the two comparison groups: abbreviated (48-hours) and prolonged antibiotics (7-days) after source control.
Aim#3: Identify a critical threshold of biochemical procalcitonin or a % decrease in procalcitonin from the initial procalcitonin obtained upon admission that suggests resolution of systemic infection in patients with NSTI. This will be done by obtaining a serum procalcitonin upon admission and daily for up to 7 days from admission or once source control has been achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult patients 18 years of age or older with all following criteria:
- •Presenting to the Emergency Department with history, exam and/or imaging concerning NSTI, AND
- •Patients who undergo consultation by the Emergency General Surgery service, AND
- •Patients included must have skin or soft tissue findings consistent with NSTI (erythema, crepitus, or pain out of proportion to exam), AND
- •Systemic signs of infection including fever (temperature >38.0°C) or leukocytosis (≥11,000 peripheral white cells per cubic millimeter), AND
- •Patients who undergo excisional debridement and/or amputation to achieve source control.
排除标准
- •Pregnant patients
- •Prisoners
- •Patients with bacteremia upon admission
- •Patients unable to provide consent (including no legally authorized representative)
研究组 & 干预措施
Long course of antibiotics
Patients assigned to a 7 day course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient
干预措施: Antibiotic duration (extended course) (Other)
Short course of antibiotics
Patients assigned to a 48-hour course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient
干预措施: Antibiotic duration (short course) (Other)
结局指标
主要结局
Safety of the antibiotic course duration
时间窗: Through study completion, an average of 1 year
In-hospital complications
Mortality rate
时间窗: Through study completion, an average of 1 year
In-hospital mortality
次要结局
- BMI (body mass index)(Baseline, pre-intervention/procedure/surgery)
- Serum concentration of C-reactive protein(Through study completion, an average of 1 year)
- Serum concentration of glucose(Through study completion, an average of 1 year)
- Total ventilator days(Through study completion, an average of 1 year)
- Blood Pressure(Baseline, pre-intervention/procedure/surgery)
- Heart Rate(Baseline, pre-intervention/procedure/surgery)
- NSTI location(Baseline, pre-intervention/procedure/surgery)
- Serum concentration of procalcitonin(Upon admission and daily blood sample for 7 days)
- Serum concentration of white blood cell(Through study completion, an average of 1 year)
- Serum concentration of hemoglobin(Through study completion, an average of 1 year)
- Serum concentration of creatinine(Through study completion, an average of 1 year)
- Age(Baseline, pre-intervention/procedure/surgery)
- Respiratory rate(Baseline, pre-intervention/procedure/surgery)
- Operations(Through study completion, an average of 1 year)
- Sex(Baseline, pre-intervention/procedure/surgery)
- Temperature(Baseline, pre-intervention/procedure/surgery)
- Comorbidities(Baseline, pre-intervention/procedure/surgery)
- Transfusion requirements(Baseline, pre-intervention/procedure/surgery)
- Serum concentration of sodium(Through study completion, an average of 1 year)
- Total intensive care unit (ICU)(Through study completion, an average of 1 year)
- Total hospital length of stay(Through study completion, an average of 1 year)
研究者
Areg Grigorian
Assistant Clinical Professor, Surgery
University of California, Irvine