DRKS00011881招募中2 期
Open label, comparative, randomized trial of the efficacy, safety and bioavailability of highly concentrated inhalative epinephrine (4 mg L-Epinephrin/ml, Infectokrupp® Inhal) versus Epinephrin-Autoinjektor-Anwendung (Fastjekt® Junior) in infants with acute anaphylactic reaction in the course of a food challenge - TRANCHE - TReatment of ANaphylaxis in CHildrenwith Epinephrine
Charité Campus Virchow-Klinikum0 个研究点目标入组 40 人开始时间: 2017年6月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 6 Years（—）
- 性别
- All
入选标准
- •„Run-in-Phase:
- •written informed consent of the parents to study participation
- •age: 1 to 6 years of age
- •Weight 7.5 to 30 kg
- •planned inpatient admission in the context of a medically indicated oral food challenge
- •Treatment”-Phase:
- •treatment-requiring anaphylactic reaction in the course of the oral food challenges, defined as:
- •(1.) at least two affected organ systems (skin, gastrointestinal tract, airways, and/or heart/circulation) with an anaphylaxis symptom score of at least 5 points or
- •(2.) peripheral or central airway obstruction or
- •(3.) drop in blood pressure (reduced systolic blood pressure 70 mm Hg plus 2 x age in years or drop in blood pressure: >30% drop of the systolic blood pressure)
排除标准
- •- acute febrile infection
- •- known clinically relevant cardiac and circulatory disorders such as angina pectoris, obstructive cardiomyopathy, cardiac arrhythmias, coronary heart vessel diseases, diseases of the heart muscle, sclerotic vascular changes, cor pulmonale or atherosclerosis and clinically relevant hypertension
- •- known clinically relevant diabetes
- •- known hypercalcemia or hypokalemia
- •- known hyperthyroidism
- •- known phaeochromocytoma
- •- known severe renal impairment or
- •- bladder voiding disorders with residual urine formation
- •- known angle-closure glaucoma
- •- known other serious diseases which, according to the investigator’s judgement, hinder a participation
- •- known presence of other contraindications according to the medicinal product’s professional information of the investigetional products used (Infectokrupp® Inhal, Fastjekt® Junior), in particular the use of a contraindicated concomitant medication (see below)
- •- anamnestically known hypersensitivity reactions to components of one of the investigational products used, in particular sodium metabisulfite
- •- Prior participation in this study
- •- Participation in a clinical trial in the last 30 days
- •- inability of the parents to understand the study instructions; obvious unreliability or lack of cooperation of the parents
- •- use/intake of any of the following contraindicated concomitant medications or therapies:
- •- beta-blocker or alpha-receptor blocker
- •- digitalis glycosides, quinidines, halothane or cyclopropane
- •- levodopa, parasympatholytics (e.g. atropine)
- •- sympathomimetics, e.g. orciprenaline
- •- tri- and tetracyclic antidepressants
- •- monoamine oxidase inhibitors
- •- guanethidine, L-thyroxine
- •- oxytocin, ornipressin, carbazochrom
- •- insuline, antidiabetic drugs
- •- reserpine, mecamylamine
- •- certain antihistamines: diphenhydramine, chlorphenamine
- •- preparations which lead to potassium loss, e.g. potassium withdrawing diuretics, aminophylline or theophylline
- •- alcohol-containing preparations
- •- antihistamines or leukotriene receptor antagonists during the last 72 hours
- •- long-acting beta-2-mimetics or theophylline during the last 48 hours
- •- lack of willingness to store and transfer pseudonymized disease data within the limits of the clinical trial
- •- Accommodation in an institution by judicial or administrative order
- •- Patients and parents who are dependent on the investigator, the sponsor or the investigational site
研究者
相似试验
已完成
不适用
A study comparing the efficacy of clindamycin plus quinine with coartem for treating Kenyan children with uncomplicated falciparum malariaMalariaPACTR201209000419241Kenya Medical Research Institute384
进行中（未招募）
3 期
A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist reliever therapy regimen in children with mild asthmaRespiratory - AsthmaAsthmaACTRN12620001091998Medical Research Institute of New Zealand360
已完成
不适用
Open-labelled randomized controlled trial of the effect of PDA-based self-care system for type 2 diabetes versus usual care.type II DMJPRN-UMIN000002992Stress Science and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo30
已完成
不适用
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitustype 2 diabetes mellitusJPRN-UMIN000025122Kanagawa-ken Keiyu-kai Keiyu hospital20
尚未招募
3 期
A study on the effect of Ayurvedic complementary food.CTRI/2023/06/053488il