Azithromycin for treatment of hospitalized children with asthmatic symptoms

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

1 Jul 2024 → ongoing

Decision date (initial)

2024-06-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512605-29-01

ClinicalTrials.gov

NCT05028153

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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.

Secondary objectives 1

1. The secondary purpose of the study is to focus on examining the individual response to treatment. The expectation is thus that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. It is also expected that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.

Conditions and MedDRA coding

Childhood asthma

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 8

1. 1) Known allergy to macrolide antibiotics.
2. 2) Known impaired liver function.
3. 3) Known renal impairment.
4. 4) Known with neurological or psychiatric diseases.
5. 5) Known with congenital or documented acquired QT interval.
6. 6) Known with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
7. 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. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Duration (in days) of the asthma-like episode from the start of randomization.

Secondary endpoints 7

1. 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.
2. 2) The length of hospitalization.
3. 3) Need for SABA during the asthma-like episode.
4. 4) Need for oral corticosteroids (OCS) during the asthma-like episode.
5. 5) Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways.
6. 6) Percentage of days away from daycare offers and / or work for parents / guardians.
7. 7) Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Herlev Ringvej 75

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

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

Contact name

Jakob Stokholm

Public contact point

Organisation

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

Contact name

Jakob Stokholm

Sponsor responsibilities

Article 77 compliance

Region Hovedstaden

Contact point sponsor

Region Hovedstaden

Article 77 implementation

Region Hovedstaden

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications