Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteremia: a Multicenter, Randomized Clinical Trial (SHORTEN-2) With a DOOR / RADAR Analysis
概览
- 阶段
- 4 期
- 干预措施
- Short-treatment of any active antibiotic regimen
- 疾病 / 适应症
- Bloodstream Infection
- 发起方
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- 入组人数
- 306
- 试验地点
- 37
- 主要终点
- Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
Phase IV, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by P. aeruginosa (BSI-PA).
详细描述
The project is designed to determine the optimal duration of antibiotic treatment for Pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). The evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives. Active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose. Clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment. This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 90 days after the first positive blood culture.
研究者
入排标准
入选标准
- •Main inclusion criteria:
- •Adult patients with diagnosis of BSI-PA who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization.
- •Informed consent signed.
排除标准
- •Bacteremia source not adequately controlled at least 72h before randomization.
- •Bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days
- •Coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment.
- •Bacteremic pneumonia in severely immunosuppressed patients
- •Bacteremia of any origin in patients with severe neutropenia (\<500 cells / mm3) at the time of randomization.
研究组 & 干预措施
Short-treatment of any active antibiotic regimen
7 days of any active antibiotic treatment from the date of the last positive blood culture
干预措施: Short-treatment of any active antibiotic regimen
Long-treatment of any active antibiotic regimen
14 days of any active antibiotic treatment from the date of the last positive blood culture
干预措施: Long-treatment of any active antibiotic regimen
结局指标
主要结局
Probability of achieving better DOOR/RADAR score for patients in the experimental group than in the control group
时间窗: 30 days after treatment withdrawal
Probability of any given patient in the experimental arm to achieve better results than a patient in the control group assessed through their score in the DOOR/RADAR ( Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk) analysis. This analysis categorizes patients in two steps: 1. A first ordinal clinical outcome ranking (DOOR), defined by the following mutually excluding categories: 1. Healing without incidences. 2. Healing with a proven or probable recurrence. 3. Healing with a serious adverse event. 4. No clinical cure. 5. Death. 2. A second classification in which patients from the same clinical outcome category are ranked according to the number of days of antibiotic treatment (RADAR). Patients with a lower DOOR/RADAR score will be those with best outcomes in terms of clinical effectiveness as well as reduced exposure to antibiotic treatment.
次要结局
- Non-inferiority secondary endpoint; Treatment failure(Day +30 from trial treatment interruption)
- Recurrence of infection(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)
- Describe the superinfections(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)
- Confirmation of origin of recurrences(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)
- Mortality from any cause(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)
- Safety of antibiotic treatment(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture and weighted by 1,000 days of follow-up.)
- Efficiency of the short-treatment arm(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)
- Comparison of ecological impact of short and long treatment regimens(Day +30 from trial treatment interruption and day +90 from the date of extraction of the first positive blood culture.)