Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,030
- 试验地点
- 11
- 主要终点
- Desirability of Outcome Ranking (DOOR)
研究概览
简要总结
The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment.
详细描述
This is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 United States hospitals with the overarching goal of determining whether the optimal approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between patients with GN-BSI receiving IV antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. The study hypothesis is that oral treatment will result in a more favorable DOOR distribution than IV treatment, likely as a result of differential adverse events and changes in Quality of Life (QoL) profiles.
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
- •Adult (≥ 18 years) at the time of screening
- •Hospitalized
- •Identification of at least one Gram-negative organism in a blood culture
- •Capable of providing written informed consent (includes through a legally authorized representative)
- •Willingness to adhere to assigned study arm
- •Capable and willing to complete a follow-up QoL interview (including through a legally authorized representative)
排除标准
- •Unable to tolerate or absorb a course of oral antibiotics
- •Actively receiving vasopressors
- •Gram-negative organism not susceptible to any oral antibiotics
- •Gram-negative organism not susceptible to any IV antibiotics
- •Polymicrobial bloodstream infection
- •The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism (grown in addition to an Enterobacterales species or Pseudomonas aeruginosa
- •Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.
- •Anticipated duration of therapy greater than 14 days
- •Central nervous system infection
- •Absolute neutrophil count of <500 cells/mL or anticipated to reduce to <500 cells/mL during the antibiotic treatment course.
- •Receiving hospice care
研究组 & 干预措施
Intravenous Antibiotics
IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
干预措施: Intravenous Antibiotics (Drug)
Oral Antibiotics
Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
干预措施: Oral Antibiotics (Drug)
结局指标
主要结局
Desirability of Outcome Ranking (DOOR)
时间窗: Day 30
Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).
次要结局
- Incidence of All Cause Mortality(Day 30)
- Frequency of Recurrent infection(Day 30)
- Length of stay (days)(Day 30)
- Number of Participants with Treatment-related adverse events(Day 30)