2024-512605-29-01招募中2 期
Azithromycin for treatment of hospitalized children with asthmatic symptoms - A double-blind, randomized, controlled study
Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)3 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年6月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Duration (in days) of the asthma-like episode from the start of randomization.
研究概览
简要总结
To investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, we will instead include hospitalized children who provide a more diverse group than the COPSAC2010 cohort.
研究设计
- 分配方式
- Randomized
- 主要目的
- Azithromycin for treatment of hospitalized children with asthmatic symptoms
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Previous episode (s) with asthma-like symptoms and/have medical treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA.
- •The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
- •The child is between 12-71 months old.
- •Fluent Danish skills with parents / guardians.
排除标准
- •Known allergy to macrolide antibiotics.
- •Known impaired liver function.
- •Known renal impairment.
- •Known with neurological or psychiatric diseases.
- •Known with congenital or documented acquired QT interval.
- •Known with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
- •Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)> 50 and / or Fever: temperature> 39 ° C and / or C-reactive protein (CRP)> 50).
- •Use of other medications, with possible Azithromycin interactions: ○ Azithromycin may increase the effect of cecal alkaloids with risk of ergotism. The combination is contraindicated. ○ The absorption of azithromycin is inhibited by simultaneous administration of antacids. ○ Azithromycin is antagonistic in vitro to the bactericidal effect of penicillins and cephalosporins. ○ Azithromycin can increase the concentration of: ■ ciclosporin ■ colchicine ■ digoxin ■ pimozide ■ tacrolimus ○ Caution when administering drugs that prolong the QT interval, e.g. amiodarone and other class IA and III antiarrhythmics and when treating with warfarin. ○ Azithromycin may increase the incidence of side effects during treatment with rifabutin.
结局指标
主要结局
Duration (in days) of the asthma-like episode from the start of randomization.
Duration (in days) of the asthma-like episode from the start of randomization.
次要结局
- 1) Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary.
- 2) The length of hospitalization.
- 3) Need for SABA during the asthma-like episode.
- 4) Need for oral corticosteroids (OCS) during the asthma-like episode.
- 5) Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways.
- 6) Percentage of days away from daycare offers and / or work for parents / guardians.
- 7) Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).
研究者
Jakob Stokholm
Scientific
Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
研究点 (3)
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