2025-523120-53-00招募中4 期
Prospective Multicenter Randomized Non-Inferiority Study Comparing 7 Days Versus 14 Days of Antibiotic Treatment for Graft Pyelonephritis in Kidney Transplant Recipients (KTI)
Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL7 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2026年1月2日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 7
- 主要终点
- Definida a los 90 días de la inclusión por: Mortalidad por cualquier causa, o recurrencia de la pielonefritis del injerto, o reingreso por cualquier causa después del alta hospitalaria por el episodio de pielonefritis.
研究概览
简要总结
The primary objective of the study is to demonstrate the non-inferiority of a 7-day treatment regimen compared to 14 days of antibiotic treatments used in usual clinical practice in patients with graft pyelonephritis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult kidney transplant recipients ≥ 18 years of age, of both sexes, who experience an episode of acute graft pyelonephritis at any time from the transplant to 48 hours after the start of antibiotic treatment.
- •Patients must be willing and able to provide written informed consent for the trial. If a subject is unable to provide written informed consent independently, a legal representative may do so in their place.
排除标准
- •Clinical instability 48 hours after the start of antibiotic treatment due to an episode of acute graft pyelonephritis defined as: hypotension, anuria, fever equal to or greater than 38ºC, need for vasopressor drugs or admission to the intensive care unit.
- •Pregnant or breastfeeding patients.
- •Patients with known anatomical alterations that predispose to urinary tract infections (such as vesicoureteral reflux or obstructive prostatic hypertrophy).
- •Presence of urinary catheters such as bladder catheters or ureteral catheters.
- •Presence of complications such as urinary obstruction or kidney abscess.
- •Kidney transplant recipients admitted for an episode of graft pyelonephritis in the previous 30 days.
- •Participation in another clinical trial in which the protocol establishes antibiotic treatment for pyelonephritis.
- •Previous inclusion in the present study.
- •No authorization from the patient or their legal representative to sign the informed consent.
- •Any medical, psychiatric, or family condition that, in the investigator's judgment, could jeopardize or compromise the patient's ability to participate in the study.
研究组 & 干预措施
CEFTRIAXONE
Test
干预措施: CEFTRIAXONE (Drug)
CEFTRIAXONE
Comparator
干预措施: CEFTRIAXONE (Drug)
CIPROFLOXACIN
Comparator
干预措施: CIPROFLOXACIN (Drug)
CIPROFLOXACIN
Test
干预措施: CIPROFLOXACIN (Drug)
结局指标
主要结局
Definida a los 90 días de la inclusión por: Mortalidad por cualquier causa, o recurrencia de la pielonefritis del injerto, o reingreso por cualquier causa después del alta hospitalaria por el episodio de pielonefritis.
Definida a los 90 días de la inclusión por: Mortalidad por cualquier causa, o recurrencia de la pielonefritis del injerto, o reingreso por cualquier causa después del alta hospitalaria por el episodio de pielonefritis.
次要结局
- Total days of antibiotics since diagnosis of graft pyelonephritis.
- Total days of intravenous antibiotics since diagnosis of graft pyelonephritis.
- Total days of admission since diagnosis of graft pyelonephritis.
- Number of adverse events and interactions with concomitant treatments during hospitalization and at 90 days after the patient's inclusion in the study.
- Episodes of catheter-related adverse events during admission and at 90 days after the patient's inclusion in the study.
- Episodes of Clostridioides difficile at 90 days after the patient's inclusion in the study.
- Evolution of renal function at 90 days from the patient's inclusion in the study.
- Episodes of rejection and graft loss within 90 days of the patient's inclusion in the study.
- Isolated microorganisms and antibiotic sensitivity in control urine cultures at 30 and 90 days after the patient's inclusion in the study.
研究者
Núria Sabé Fernández
Scientific
Bellvitge University Hospital
研究点 (7)
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