ISRCTN71987471进行中（未招募）3 期
Multi-centre, randomised, open-label, blinded endpoint assessed trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms in Kawasaki disease (KD-CAAP: Kawasaki Disease Coronary Artery Aneurysm Prevention trial)
niversity College London0 个研究点目标入组 262 人开始时间: 2020年3月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 262
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36703139/ (added 27/01/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 30 days (post-natal age) to 15 years inclusive, and below the country-specific age of consent
- •2. KD defined in at least one of the three following ways:
- •2.1. As per American Heart Association (AHA) criteria: namely fever for at least five days in addition to 4 of the following 5 criteria:
- •2.2.1. Bilateral non purulent conjunctivitis
- •2.2.2. Cervical lymphadenopathy
- •2.2.3. Polymorphous skin rash
- •2.2.4. Changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)
- •2.2.5. Extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)
- •2.2. OR less than 5 days of fever but all five clinical criteria above
- •2.3. OR incomplete KD cases, as per a modified*AHA definition, namely:
- •2.3.1. Children/adolescents (> 1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above; OR infants < = 1 year old with fever > = 7 days without other explanation;
- •AND for both age groups:
- •2.3.2. CRP > = 30 mg/L or erythrocyte sedimentation rate (ESR) > = 40 mm/h (or both)
- •AND for both age groups
- •2.3.3. EITHER the presence of any 3 or more of: anaemia for age (haemoglobin < lower limit of normal reference range for local laboratory) platelet count > = 450 x10?/L or < 140 x10?/L; albumin < 30 g/L; elevated ALT (> upper limit of normal reference range for local laboratory); white cell count > = 15 x10?/L; urine > = 10 white blood cells per high power field
- •2.3.4. OR abnormal echocardiogram compatible with KD but without established CAA, with > = 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2< Z< 2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).
- •3. Written informed consent from appropriate legal representative(s), and assent from patients who have not reached the age of consent in the participating country, but are judged to have capacity for this (depending on both age and acuity of illness)
- •*This definition of incomplete KD is modified from the AHA definition by firstly, the exclusion of aneurysmal coronary artery changes as the sole echo finding, since this is an exclusion criterion for KD-CAAP, and secondly the inclusion of low platelet count as well as high platelet count, as highlighted in recent European consensus SHARE guideline.
- •Note that patients with KD can still be included in KD-CAAP if they have started IVIG treatment, as long as they are randomised no more than 24 hours after the IVIG infusion is initiated (see exclusion criteria below).
- •Test results must be from tests done on the calendar day of randomisation or the day before.
排除标准
- •Disease-related exclusions:
- •1. This diagnosis is a second or further episode of KD
- •2. Already established CAA at screening
- •3. Severe Congestive Heart Failure or cardiogenic shock defined as the presence of hypotension and shock requiring the initiation of volume expanders
- •4. Known congenital coronary artery abnormality that would impair assessment of the primary endpoint
- •5. Suspected macrophage activation syndrome
- •Exclusions related to medications:
- •6. Started IVIG more than 24 hours prior to randomisation
- •7. Known hypersensitivity to prednisolone or methylprednisolone
- •8. Current oral, intravenous or intramuscular corticosteroid treatment for more than 3 days in previous 7 days prior to randomisation
- •9. History of previous severe reaction to any human immune globulin preparation
- •Exclusions related to general health or other issues:
- •10. Active varicella zoster virus infection; or known exposure to a case of varicella within the previous 21 days prior to randomisation if known to be non-immune
- •11. Co-enrolment in another study/trial of an investigative medicinal product
研究者
相似试验
已完成
不适用
A randomised multicentre open label blinded end point trial to compare the effects of spironolactone to chlortalidone on left ventricular mass in stage 2 and stage 3 chronic kidney diseaseTopic: Cardiovascular, Renal and UrogenitalSubtopic: Cardiovascular (all Subtopics), Renal and Urogenital (all Subtopics)Disease: Cardiovascular, RenalCirculatory SystemISRCTN94696478niversity of Birmingham (UK)154
已完成
不适用
Comparing the clinical effectiveness, acceptability and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosaAnorexia nervosaISRCTN10166784King's College London15
已完成
4 期
Study of oral EGb 761® Ginkgo biloba extract added to standard treatment after acute strokeAcute ischemic strokeCirculatory SystemStroke, not specified as haemorrhage or infarctionISRCTN11815543Dr Willmar Schwabe (Germany)201
已完成
2 期
SMILE: Strategy for Maintenance of HIV suppression with dolutegravir + darunavir/ritonavir in children (PENTA 17)HIV infectionInfections and InfestationsISRCTN11193709PENTA Foundation318
进行中（未招募）
不适用
A clinical trial to evaluate the efficacy and safety of Shufeng Jiedu capsule in acute exacerbation of chronic obstructive pulmonary disease (COPD)Chronic obstructive pulmonary diseaseRespiratoryISRCTN99049821Beijing University of Chinese Medicine300