Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
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
- 1
- 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
The purpose of this double-blind, randomized, controlled clinical trial is 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.
详细描述
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. 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, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
The study hypothesis is:
● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy 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 for 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).
研究组 & 干预措施
Antibiotics
Azithromycin (10mg/kg) administered via oral suspension for 3 consecutive days
干预措施: Azithromycin Oral Liquid Product (Drug)
Placebo
Placebo with no active substance administered via oral suspension for 3 consecutive days
干预措施: Placebo mixture (Other)
结局指标
主要结局
Duration in days of the asthma-like episode from the start of randomization.
时间窗: 1-30 days
Number of days based on a diary.
次要结局
- Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s)(1-30 days)
- Change in symptom score.(From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.)
- Effect modification in relation to the child's respiratory microbiota profile.(Sample time, day 1)
- Need for SABA during the asthma-like episode(1-30 days)
- Number of days away from daycare offers.(1-30 days)
- Resistance profiles(1-30 days)
- Effect modification in relation to the child's respiratory immunological profile.(Sample time, day 1)
- Stratification of the above analyzes.(Sample time, day 1)
- The length of hospitalization (days)(1-30 days)
- Adverse Event (AE) registration(1-30 days)
- Need for oral corticosteroids (OCS) during the asthma-like episode.(1-30 days)
- Gut microbiome profile(1-30 days)