2024-513328-40-00
招募中
4 期
SHORTCUT - Efficacy of 7 days versus 14 days of antibiotic therapy for acute pyelonephritis in kidney transplant recipients, a multicenter randomized non-inferiority trial
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris7 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2024年6月19日最近更新:
干预措施-
概览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
- 入组人数
- 470
- 试验地点
- 7
- 主要终点
- Clinical cure and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI.
概览
简要总结
To show that a 7 day-antibiotic therapy is not inferior to a 14 day-antibiotic therapy in the treatment of acute pyelonephritis in kidney transplant recipients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age >18 years Kidney Transplant Recipients
- •APN defined by: fever (T°≥38°C) (with or without clinical signs and/or symptoms of UTI) and pyuria (≥104 white blood cells/mL or ≥10/mm3) and positive urine culture (uropathogen ≥103 CFU/mL susceptible to the empirically administrated antibiotic)
- •No confirmed or suspected febrile non urinary bacterial infection
- •No urologic/renal complication at baseline imaging (abscess, obstruction...)
- •Favourable early response to antibiotic treatment:( 48 to 60 hours after the first dose of antibiotic effective against the causative uropathogen) defined by: T°<38°C and improvement (or resolution) of signs and/or symptoms of urinary tract infection if present at diagnosis.
- •Written informed consent
排除标准
- •Patients with any of the following conditions
- •First month post transplantation
- •Current indwelling catheter (including bladder catheter, ureteral stents, percutaneous nephrostomy tubes)
- •Neurogenic bladder
- •Enterocystoplasty
- •Immunodeficiency or immunosuppressive therapy not related to kidney transplantation, including hematologic malignancy, cancer, asplenia, neutropenia<500 neutrophils/mm3,
- •Pregnancy, breastfeeding
- •Hypersensitivity or previous severe adverse drug reaction to the antibiotic therapy
- •Unable or unwilling, in the judgment of the investigator, to comply with the protocol
- •Life expectancy<1 month
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Clinical cure and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI.
Clinical cure and no additional antibiotic treatment since the end of antibiotic treatment up to the main evaluation at day 30. Clinical cure is defined as fever <38°C and no symptoms of UTI.
次要结局
- Clinical cure at day 90 and 180
- Microbiological cure *at day 30, 90 and 180
- Incidence of relapse /recurrence between day 30 and day 90
- Incidence of adverse events imputable to antibiotic treatment
- Kidney function assessed according to MDRD (Modification of Diet in Renal Disease) or CKD (Chronic Kidney Disease - Epidemiology Collaboration) epi
- Hospitalization length stay defined by the delay between the date of inclusion and the date of hospital discharge
- Antibiotic consumption
- Rectal carriage of antibiotic resistant Enterobacteriaceae at inclusion and day 30
研究者
Dr. Matthieu LAFAURIE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
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