EUCTR2021-003847-10-ES进行中（未招募）1 期
Efficacy and safety of 7 versus 14 days of antibiotic treatment for Pseudomonas aeruginosabacteraemia: a multicentre, randomized clinical trial (SHORTEN-2) with a DOOR/RADAR analysis
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)0 个研究点目标入组 304 人开始时间: 2021年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Diagnosis of P. aeruginosa bacteremia.
- •3. 4 to 6 days of active antimicrobial treatment.
- •4. Informed consent of patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1. Age < 18 years.
- •2. Pregnancy.
- •3. Source of bacteriemia not properly controlled at the moment of randomisation.
- •4. Bacteremia secondary to an infection necesarilly requiring prolonged antibiotic treatment, including necrotizing or postobstructive pneumonia, lung abscesses, clinical suspicion of acute prostatitis, bone and joint infections, central nervous system infections and endovascular infections related to vascular protheses.
- •5. Coexistence of a different infection at the diagnosis of the bacteremia that also requires prolonges antibiotic treatment.
- •6. Bacteremic pneumonia in severely immunocompromised hosts, defined as: neutropenia <500 cells/mm3,
- •recipients of allogenic hematopoietic stem cell or solid organ transplant during their first year after
- •transplantation, active graft versus host disease requiring immunosuppresive treatment, patients with solid
- •tumours undergoing chemotherapy, untreated HIV infection with CD4 bellow 200 cells/mm3, combined
- •primary immunodeficiency, or treatment with steroids with prednisone >20mg/day (or equivalent) during
- •the 14 days preceding the randomisation.
- •7. Bacteremia from any source in patients who maintain neutropenia bellow 500 cells/mm3 at the moment of
- •randomisation.
- •8. Bacteremia from any source in major burns.
- •9. Bacteremia produced by strains resistant to all betalactams and quinolones.
- •10. Polymicrobial bacteremia including microorganisms different to P. aeruginosa.
- •11. Patients with expected survival inferior to 48h from the moment of randomisation.
- •12.Patients that have received more than 7 days of active antibiotic treatment for the isolated P. aeruginosa strain in blood at the moment of the inclusion.
- •13. Bacteremia by P. aeruginosa in the previous 90 days.
- •14. The patient´s responsible clinician does not want to include the patient in the clinical trial.
研究者
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