BridgeMD
TRALULALA-AZI
EU CTIS ID: 2024-518730-88-00
What this study is testing
To determine the efficacy of 6 months of maintenance treatment with AZI on incidence of respiratory exacerbations in subjects with structural lung damage or congenital lung and airway malformations, 0-72 months of age
- Therapeutic use (Phase IV)
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
- Radiologically or/and bronchoscopy verified structural lung damage or congenital lung and airway malformations
- Outpatient affiliation with one of the three specialized pediatric pulmonology centers in Denmark.
- At risk of or already documented respiratory infections requiring antibiotics.
- Age between 0-72 months.
- Parents provide written informed consent for their child to participate in the trial, according to local regulations.
You likely can't join if
- Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study
- Current treatment with medication known to interact with AZI: ciclosporin, coumarin-like oral anticoagulants (e.g. warfarin), digoxin, ergotamine derivatives (e.g. methylergometrine), nelfinavir, rifabutin and active substances known to prolong QT interval such as amiodarone and other class ΙA and class ΙΙΙ antiarrhythmics, cisapride, terfenadin, moxifloxacin and levofloxacin, antipsychotic agents such as pimozide and antidepressants such as citalopram
- Cystic fibrosis (CF) or Primary Ciliary Dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded
- Children already receiving AZI 3 times a week to prevent infections
- Impaired liver function: Children with an alanine transaminase (ALAT) > twice the upper limits of normal will be excluded
- Impaired kidney function: Children with GFR < 50 ml/min will be excluded
See the full eligibility criteria
- Radiologically or/and bronchoscopy verified structural lung damage or congenital lung and airway malformations
- Outpatient affiliation with one of the three specialized pediatric pulmonology centers in Denmark.
- At risk of or already documented respiratory infections requiring antibiotics.
- Age between 0-72 months.
- Parents provide written informed consent for their child to participate in the trial, according to local regulations.
- Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study
- Current treatment with medication known to interact with AZI: ciclosporin, coumarin-like oral anticoagulants (e.g. warfarin), digoxin, ergotamine derivatives (e.g. methylergometrine), nelfinavir, rifabutin and active substances known to prolong QT interval such as amiodarone and other class ΙA and class ΙΙΙ antiarrhythmics, cisapride, terfenadin, moxifloxacin and levofloxacin, antipsychotic agents such as pimozide and antidepressants such as citalopram
- Cystic fibrosis (CF) or Primary Ciliary Dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded
- Children already receiving AZI 3 times a week to prevent infections
- Impaired liver function: Children with an alanine transaminase (ALAT) > twice the upper limits of normal will be excluded
- Impaired kidney function: Children with GFR < 50 ml/min will be excluded
- Neurological or psychiatric disorders will be excluded
- Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded
- Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study
- Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study
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.