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临床试验/CTIS2024-512605-29-01
CTIS2024-512605-29-01招募中1 期

Azithromycin for treatment of hospitalized children with asthmatic symptoms - A double-blind, randomized, controlled study - COPSACazt

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: 2024年5月22日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
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

入排标准

年龄范围
0 至 17(—)
性别
All

入选标准

  • 1) Previous episode (s) with asthma-like symptoms and/have medical treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA., 2) The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial., 3) The child is between 12-71 months old., 4) Fluent Danish skills with parents / guardians.

排除标准

  • 1) Known allergy to macrolide antibiotics., 2) Known impaired liver function., 3) Known renal impairment., 4) Known with neurological or psychiatric diseases., 5) Known with congenital or documented acquired QT interval., 6) Known with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure., 7) 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)., 8) 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.

研究者

发起方
Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)

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