2024-520251-24-00招募中4 期
Evidence based empirical antibiotic treatment for urinary tract infections requiring hospitalisation - TRI-AB trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 618
- 试验地点
- 7
- 主要终点
- Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)
研究概览
简要总结
To assess whether tablet pivmecillinam 800 mg three times daily combined with a single iv dose of gentamicin 5 mg/kg is non-inferior to current standard empirical treatments (iv ampicillin plus gentamicin or iv piperacillin/tazobactam) for achieving clinical cure on day 3 in hospitalised adults with cUTI
研究设计
- 分配方式
- Randomized
- 主要目的
- Tri-ab
- 盲法
- None
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
- •Hospitalised with symptoms and/or signs of acute pyelonephritis or lower cUTI
- •Empirical intravenous antibiotic treatment is planned by the treating physician
排除标准
- •quick Sequential Organ Failure Assessment Score (qSOFA) ≥2 (qSOFA score allocates one point for each of the following criteria: respiratory rate ≥22/min, altered mental status, and systolic blood pressure ≤100 mmHg)
- •Known myasthenia gravis
- •Acute mononucleosis or porphyria
- •Pre-existing complicated urogenital conditions
- •Current or earlier treatment with cisplatin and/or carboplatin
- •Descent from the Faroe Islands without prior negative screening for Carnitine Transporter Deficiency (CTD)
- •Receipt of iv antibiotics covering cUTI prior to enrollment
- •Kidney transplant recipients or patients on hemodialysis or periotoneal dialysis
- •Informed consent prior to inclusion unobtainable.
- •estimated Glomerular Filtration Rate <30ml/min/1.73m^2
- •Urine culture within 72 hours showing a microorganism resistant to one of the study regimens
- •Known allergy or hypersensitivity to pivmecillinam, penicillins, cephalosporins, aminoglycosides or excipients
- •Pregnancy or breastfeeding
- •Inability to ingest oral medication
研究组 & 干预措施
PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
Comparator
干预措施: PIPERACILLIN AND BETA-LACTAMASE INHIBITOR (Drug)
PIVMECILLINAM
Test
干预措施: PIVMECILLINAM (Drug)
AMPICILLIN
Comparator
干预措施: AMPICILLIN (Drug)
GENTAMICIN
Test
干预措施: GENTAMICIN (Drug)
结局指标
主要结局
Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)
Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)
次要结局
- 30/90/365-day mortality
- Microbiological cure on Day 3
- Time to oral-only antibiotic therapy
- Length of hospital stay
- Antibiotic treatment duration (combined iv and oral)
- Nephrotoxicity within 30 days
- Proportion of treatment-related serious adverse reactions (SAE) and suspected unexpected serious adverse reactions (SUSAR)
- Secondary infections (C. difficile or genital/oral Candida within 30 days of enrollment)
- Hospital readmission within 90 days due to UTI
- Post-discharge antibiotic prescription redemption within 90 days for UTI associated antibiotics.
研究者
TRI-AB
Scientific
Odense University Hospital
研究点 (7)
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