2024-514244-81-00撤回3 期
CANDISHORT : A randomized study of a short duration therapy for candidemia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 399
- 试验地点
- 20
- 主要终点
- The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.
研究概览
简要总结
To demonstrate that, in uncomplicated candidemia, a duration of treatment of 7 days after the first negative blood culture is non-inferior to a duration of 14 days after the first negative blood culture for all-cause mortality (ACM) at Day 28 (+/- 2 days).
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 (Age ≥ 18 years old) with a predicted life expectancy > 4 weeks
- •With a positive Candida sp. blood culture allowing the diagnosis of candidemia
- •Results of the 1st positive blood culture less than 72 hours at the time of inclusion
- •If the patient is in aplasia (defined by neutrophil count below 500/mm3), predictive duration of aplasia must be less than 7 days
- •Individual affiliated to a social security regimen
- •Written informed consent from the patients or his/her relatives
排除标准
- •Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment
- •Candida strain resistant to the antifungal used
- •Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments
- •Patient under legal guardianship
- •Pregnancy, breastfeeding
- •Women with childbearing age who has not used or does not plan to use acceptable birth control measures
- •Unwilling, in the judgment of the investigator, to comply with the protocol
结局指标
主要结局
The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.
The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.
次要结局
- Proportion of randomized patients with secondary localizations
- Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture
- Liver function tests (ASAT, ALAT, GGT, PAL, bilirubin blood levels) according to the two treatment strategies at inclusion (Visit 1) randomization (Visit 2), at D14 (+/- 2 days) (Visit 3) (D1: day of the 1st drawn negative blood culture)
- Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized
- Proportion of randomized patients with relapse at D45 (+/- 2 days)
- Proportion of randomized patients with secondary localization at D45 (+/- 2 days)
研究者
Dr Blandine Denis (Coordinating investigator)
Scientific
Assistance Publique Hopitaux De Paris
研究点 (20)
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