2025-521478-32-00招募中3 期
ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS. ANAPEM
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 11
- 主要终点
- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.
研究概览
简要总结
To compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units.
研究设计
- 分配方式
- Randomized
- 主要目的
- Anapem
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children from ≥ 3 months to < 18 years of age
- •Hospitalized in the Intensive Care Unit (ICU) for acute myocarditis defined as : - a reduced left ventricle ejection fraction below 50% and - troponin T rise (>1.5x normal range)
- •Signed informed consent by legal representative and patient according to the legislation.
排除标准
- •Children weighing less than 5 Kgs
- •Anti TNF-α within the past 14 days
- •Malignancy or history of malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
- •Ongoing or recent use of any other medication Known inhibitors/inducers of cytochrome P450
- •Patients with increased risk of Tuberculosis (TB ) infection - Recent tuberculosis infection or with active TB o Close contact with a patient with TB o Patients recently arrived less than 3 months from a country with high prevalence of TB o A chest radiograph suggestive of TB
- •Patients with overt concomitant bacterial infection
- •Patients with overt concomitant bacterial infection
- •Patients with any type of immunodeficiency or cancer
- •Inability of the legal representative (and the patient, when applicable) to understand the national language (French)
- •Pregnancy** or breastfeeding
- •No affiliation to the Social Security
- •Current enrollment in another clinical trial
- •Known anterior cardiomyopathy or operated cardiopathy
- •Neutropenia (< 1,5 × 10^9 /L).
- •Known hypersensitivity to Anakinra or any of its excipients (citric acid anhydrous, sodium chloride, disodium EDTA dihydrate, polysorbate 80, E. coli derived proteins)
- •Administration of a live vaccine in the 4 weeks prior to inclusion
- •Hepatitis B infection, defined as positive HBsAg and/or detectable HBV DNA (PCR). Due to the urgent need to start treatment, inclusion may occur before hepatitis B screening results are available. If hepatitis B infection is subsequently confirmed, the study treatment will be immediately discontinued.
结局指标
主要结局
Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.
Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.
次要结局
- Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 7 and 28 days after treatment initiation. Patients who die or undergo heart transplant within the first 7 and 28 days after treatment initiation respectively will be considered as a failure (i.e, LVEF < 50%). Patients who still require ECMO at 7 and 28 days after treatment initiation respectively will also be considered as failure (i.e., LVEF < 50%).
- Time to recovery of normal left ventricular ejection fraction (LVEF ≥ 50%) within the first 3 days after treatment initiation 3- Proportion of children requiring ECMO within the first 3 days after treatment initiation
- Proportion of children requiring ECMO within the first 3 days after treatment initiation
- Proportion of children who undergo heart transplant within 6 months after treatment initiation
- Time to all-cause death within 6 months after treatment initiation
- Time to cardiovascular-related death within 6 months after treatment initiation
- Proportion of children with drug-related side effects (hypersensitivity, neutropenia, drug-related liver enzymes elevation…)
- a- o NT proBNP at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o Troponin T at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation o Proportion of children with ventricular tachycardia assessed by EKG at inclusion and at 24 hours, 48 hours, 72 hours following treatment initiation b- o NT proBNP at 7 days following treatment initiation o Troponin T at 7 days following treatment initiation o Proportion of children with ventricular tachyca
研究者
Dr Ramy CHARBEL
Scientific
Assistance Publique Hopitaux De Paris
研究点 (11)
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