Open-label, Randomized Clinical Trial to Assess the Non-inferiority of 7-day Antibiotic Therapy Compared to Conventional 14-day Treatment in Multidrug-resistant Gram-negative Bacilli Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 29
- 主要终点
- Clinical failure
研究概览
简要总结
Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens associated with multidrug resistance and HAIs. These bacteria are of special concern because few therapeutic options are available.
Traditionally, the duration of treatment for severe multidrug-resistant (MDR)-GNB infections is 14 days. Studies of severe infections by GNB, regardless of susceptibility profile, have shown that shorter antimicrobial treatments are not inferior to traditional durations of therapy and are associated with a lower incidence of adverse effects. However, there are currently no studies assessing whether shorter duration of antimicrobial treatment is effective for MDR-GNB.
This open-label, randomized clinical trial aims to assess the non-inferiority of 7-day antibiotic therapy compared to conventional 14-day treatment in severe infections by MDR-GNB.
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
- •Infection's diagnosis while in the ICU
- •Severe infection in any site (defined as the presence of sepsis/septic shock or bloodstream infection or pneumonia) associated with a positive culture by MRD-GNB (Acinetobacter baumannii complex, Pseudomonas aeruginosa, and Enterobacterales bacteria, only susceptible to carbapenems and/or polymyxins)
- •Hemodynamically stable and afebrile (axillary temperature less than 37.8ºC) for at least 48 hours on day 7 of adequate antibiotic therapy
- •Consent of the team providing care to the patient regarding their inclusion in the research
排除标准
- •Inclusion in other experimental studies involving antimicrobial therapy
- •Infections that have as the primary site: endocarditis/endovascular infection, necrotizing fasciitis, osteomyelitis, abdominal abscess or other abdominal infections requiring surgical intervention (except infections that have been treated surgically, with curative character within the first 3 days of appropriate antimicrobial therapy), central nervous system Infections, empyema, prosthetic infection;
- •Immunosuppression defined as: neutrophil cells <1000/mm³ in the current hospitalization, HIV/AIDS diagnosis with last CD4 count <200/mm³, solid organ transplantation in the last year and/or need for increased immunosuppression due to acute rejection in the last year, hematopoietic stem cell transplantation in the last year, and/or current therapy for chronic graft-versus-host disease
- •Positive blood cultures for the same pathogen within 48 hours prior to randomization, when collected
- •Uncontrolled concomitant infection with another GNB (regardless of susceptibility profile)
- •Previous inclusion in this study
- •Known pregnancy
- •Patient in palliative care who has already decided not to restart antimicrobials, if necessary, or hemodynamic support measures.
研究组 & 干预措施
7-day adequate antibiotic therapy
Adequate antibiotic therapy is defined as antimicrobial treatment with at least one agent with in vitro susceptibility.
干预措施: Duration of therapy (Other)
14-day adequate antibiotic therapy
Adequate antibiotic therapy is defined as antimicrobial treatment with at least one agent with in vitro susceptibility.
干预措施: Duration of therapy (Other)
结局指标
主要结局
Clinical failure
时间窗: 28 days after randomization
Incidence of clinical failure. Clinical failure is a composite outcome defined by the presence of one of the following: Infection relapse (infection anywhere in the body by the same MDR-GNB) or Death
次要结局
- Days alive and free from hospitalization(28 days after randomization)
- Days alive and free from any antibiotic therapy(28 days after randomization)
- Length of intensive care unit stay(28 days after randomization)
- Acute kidney injury(28 days after randomization)
- Confirmed infection by Clostridioides difficile(28 days after randomization)
- Hemodynamic instability lasting more than 6 hours(14 days after randomization)
- Other adverse events related to antimicrobial therapy(28 days after randomization)
- Diarrhea for any cause(28 days after randomization)
- Occurrence of infections caused by other MRD-GNB or other bacteria(28 days after randomization)