Azithromycin for treatment of hospitalized children with asthmatic symptoms

Phase 1

Recruiting

• Conditions: Childhood asthma, Childhood asthma; MedDRA version: 21.1Level: LLTClassification code: 10015575Term: Exacerbation of asthma Class: 10038738; MedDRA version: 21.1Level: PTClassification code: 10081274Term: Childhood asthma Class: 100000004855; MedDRA version: 20.0Level: LLTClassification code: 10003564Term: Asthma/bronchitis Class: 10038738; MedDRA version: 21.1Level: LLTClassification code: 10049176Term: Asthma-like condition Class: 10038738; MedDRA version: 21.1Level: LLTClassification code: 10003565Term: Asthmatic Class: 10038738; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2024-512605-29-01
• Lead Sponsor: Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-22
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified