Antibiotic treatment for hospitalized children with asthmatic symptoms

Phase 1

• Conditions: Childhood Asthma; MedDRA version: 21.1Level: PTClassification code 10081274Term: Childhood asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: LLTClassification code 10049868Term: Asthma exacerbation prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-004420-42-DK
• 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: 2021-11-26
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

? 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

Exclusion Criteria

? 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.

Study & Design

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