EUCTR2020-004420-42-DK进行中（未招募）1 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)0 个研究点目标入组 320 人开始时间: 2021年11月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 320
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •¦ 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.
研究者
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Azithromycin for treatment of hospitalized children with asthmatic symptomsChildhood asthma, Childhood asthmaMedDRA version: 21.1Level: LLTClassification code: 10015575Term: Exacerbation of asthma Class: 10038738MedDRA version: 21.1Level: PTClassification code: 10081274Term: Childhood asthma Class: 100000004855MedDRA version: 20.0Level: LLTClassification code: 10003564Term: Asthma/bronchitis Class: 10038738MedDRA version: 21.1Level: LLTClassification code: 10049176Term: Asthma-like condition Class: 10038738MedDRA version: 21.1Level: LLTClassification code: 10003565Term: Asthmatic Class: 10038738CTIS2024-512605-29-01Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)320
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