试验雷达 AI | ||
|---|---|---|
临床试验 NCT05922124 (CASCADE) 针对碳青霉烯耐药细菌感染，Acinetobacter Bacteremia，Acinetobacter Pneumonia目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
兰巴姆医疗园区Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii (CASCADE) IV期 734
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05922124 (CASCADE)旨在研究治疗，主要针对碳青霉烯耐药细菌感染，Acinetobacter Bacteremia，Acinetobacter Pneumonia。这是一项IV期 干预性研究试验，目前试验状态为招募中。试验始于2024年9月1日，计划招募734名患者。该研究由兰巴姆医疗园区主导，预计于2026年9月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年8月1日。
简要概括
Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.
详细描述
This will be a prospective controlled clinical study with historical controls.
In the prospective CASCADE study consecutive consenting patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia will be treated with cefiderocol combined with ampicillin sulbactam in 3 hospitals in Israel and 2 hospitals in Italy, all endemic for CRAB. We plan to recruit 150 patients into this ...
显示更多官方标题
Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)
疾病
碳青霉烯耐药细菌感染Acinetobacter BacteremiaAcinetobacter Pneumonia出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- CASCADE
- V0.1 May 2023
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Cefiderocol + ampicillin-sulbactam Cefiderocol 2 gram intravenous (IV) q8 hours and ampicillin-sulbactam 3 gram IV q6 hours for patients with normal creatinine clearance, both administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies. | Cefiderocol Test drug regimen Ampicillin-sulbactam Synergistic combination |
阳性对照Colistin or colistin + meropenem Colistin 9 million units (MIU) intravenous (IV) loading dose followed by 4.5 MIU for patients with normal creatinine clearance +/- meropenem 2 gram IV administered as extended infusion of 3 hours. Dosing adjusted according to reduced and augmented renal clearance and to renal replacement therapies. | Colistin Historical comparator 美罗培南 Historical comparator synergistic combination |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
All cause mortality | Death from any cause | 28 days |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
All cause mortality | Death from any cause | 14 days |
Clinical failure | Composite of:
* Death
* Systolic blood pressure ≤90 mmHg or need for vasopressor support
* Worsening sequential organ failure assessment score (SOFA) score, define as:
* for baseline SOFA ≥ 3: stable or increased
* for baseline SOFA \<3: any increase
* For patients with hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP), partial pressure of oxygen in arterial blood (PaO2)/ fraction of inspired oxygen (FiO2) ratio worsened
* For patients with bacteremia, growth of the initial isolate in blood cultures after ≥ 5 days since study treatment start | Day 10-14 |
Microbiological failure | Isolation of the initial isolate (phenotypically identical) in blood cultures 5 days or more after start of treatment or in respiratory samples 7 days or more. | Day 5-7 |
Resistance development to cefiderocol | Development of carbapenemase-producing Enterobacterales (CPE), non-CPE carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant A. baumannii (CRAB) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) resistance to cefiderocol in clinical and surveillance cultures collected as defined in the study's protocol | 28 days |
Hospital stay | Among 28-day survivors | 28 days |
Decline in functional capacity | Functional capacity will be assessed in four categories: independent; requires some assistance; requires assistance for activities of daily living (ADL); and bedridden. Decline in functional capacity will be defined as any 1-category worsening. | 28 days |
Adverse event - Clostridiodes difficile infection | Diarrhea with a positive C. difficile toxin test | 28 days |
Adverse event - renal failure | Renal failure due to any reason using the RIFLE ( risk, injury, failure, loss, End stage kidney disease) criteria (classifying patients to None, Risk, Injury, Failure, Loss and ESRD) at day 14 and day 28 and defined as worsening by two RIFLE categories (e.g. from Risk to Failure, etc.) | 28 days |
Adverse event - Acute liver injury | Increase in aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3-fold or increased bilirubin \>2 above upper limits of normal (ULN) or baseline value if higher than ULN. | 28 days |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
16 Years
适龄性别
全部
Adults >18 years with bacteremia or hospital-acquired pneumonia (HAP)/ ventilator-associated pneumonia (VAP) (Table 3) caused by carbapenem-resistant A. baumannii (CRAB) (meropenem and/ or imipenem minimal inhibitory concentration (MIC) >8 μg/mL) susceptible to cefiderocol (disc zone diameter >=17 mm, corresponding to an MIC <2 μg/mL). We will include CRAB regardless of colistin, ampicillin-sulbactam, minocycline, tigecycline, trimethoprim/sulfamethoxazole and/or aminoglycoside susceptibility of the isolate. Attribution of the HAP/ VAP to CRAB will be allowed with isolation of CRAB from any respiratory sample within 7 days prior to the clinical diagnosis of pneumonia.
- More than 72 hours of therapy with in-vitro coverage against the CRAB within 96 hours of enrolment
- Polymicrobial carbapenem-susceptible infections: growth of other pathogens susceptible to carbapenems, or another beta-lactam, deemed clinically-significant by the treating physicians in blood or sputum (with HAP/ VAP). We will allow recruitment of patients with other carbapenem-resistant Gram-negative bacteria
- CRAB susceptible any beta-lactam other than cefiderocol
- Coronavirus 2019 (COVID-19) co-infection
- Immediate-type hypersensitivity to penicillin
- Pregnant women
- Previous participation in the trial
- Lack of informed consent, considering the procedures acceptable to ethics committees per locale, including deferred consent
- Infection requiring treatment for over 14 days, at the discretion of the investigators
- Life expectancy less than 24 hours or expected futility of antibiotic treatment
兰巴姆医疗园区36 个活跃的临床试验可供探索- 🏥Monaldi Hospital
研究中心联系人
联系人: Mical Paul, 0502062140, [email protected]
联系人: Marco Falcone, [email protected]
3 位于 1 个国家/地区的研究中心
Rambam Health Care Campus, Haifa, Israel
Mical Paul, MD, 联系人, [email protected]
Mical Paul, MD, 主要研究者
招募中
Sheba Tel HaShomer Medical Campus, Ramat Gan, Israel
Dafna Dahav, MD, 联系人
Dafna Yahav, MD, 主要研究者
招募中
Shamir Medical Center (Assaf Harofeh), Tel Aviv, Israel
Dror Marchaim, 联系人
招募中