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Azithromycin for treatment of hospitalized children with asthmatic symptoms
EU CTIS ID: 2024-512605-29-01
What this study is testing
To investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, we will instead include hospitalized children who provide a more diverse group than the COPSAC2010 cohort.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.