AZITHROMYCIN for Childhood asthma

Stratification factors

• presence or absence of bacteria in the airways

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 2) The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial."}
• {"criterion_text":"- 3) The child is between 12-71 months old."}
• {"criterion_text":"- 4) Fluent Danish skills with parents / guardians."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Duration (in days) of the asthma-like episode from the start of randomization.","definition_or_measurement_approach":"Duration in days measured from the time of randomization until resolution of the asthma-like episode."}

Secondary endpoints

• {"endpoint_text":"- 1) Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary.","definition_or_measurement_approach":"Change in symptom score measured using a previously validated symptom scoring model based on a diary from day 1 after randomization until episode completion."}
• {"endpoint_text":"- 2) The length of hospitalization.","definition_or_measurement_approach":"Measured as number of days hospitalized for the episode."}
• {"endpoint_text":"- 3) Need for SABA during the asthma-like episode.","definition_or_measurement_approach":"Recorded use/requirement of short-acting beta-agonist (SABA) during the episode."}
• {"endpoint_text":"- 4) Need for oral corticosteroids (OCS) during the asthma-like episode.","definition_or_measurement_approach":"Recorded requirement/use of oral corticosteroids during the episode."}
• {"endpoint_text":"- 5) Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways.","definition_or_measurement_approach":"Analyses stratified by presence versus absence of bacteria detected in the airways (microbiological assessment)."}
• {"endpoint_text":"- 6) Percentage of days away from daycare offers and / or work for parents / guardians.","definition_or_measurement_approach":"Calculated percentage of days absent from daycare (child) and/or work (parents/guardians) attributable to the episode."}
• {"endpoint_text":"- 7) Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).","definition_or_measurement_approach":"Health-economic assessment comparing treatment costs and lost earnings for parents/guardians to estimate economic benefit."}

Methods

• Recruitment of hospitalized children aged 1-5 years at participating pediatric departments in Denmark (inpatient recruitment at trial sites).
• Recruitment via posters in waiting rooms (document titled 'Poster waiting room' provided for publication) targeted at parents/guardians in Denmark.

Denmark

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

04-10-2024

Processing Time Days

122

Number Of Sites

3

Number Of Participants

320

Primary sponsor

Full Name

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

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark