Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations Azithromycin AZI for Airway Infection Prevention
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations a Randomized Controlled Trial on Azithromycin AZI for Airway Infection Prevention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRALULALA-AZI
Brief Summary:
Children with lung and airway malformations or early structural lung damage face significant challenges often leading to recurrent respiratory infections hospitalizations and decreased quality of life Despite various interventions effective strategies are urgently needed
The link between these conditions and persistent bacterial bronchitis remains unclear possibly due to compromised airways and reduced mucociliary clearance Although antibiotics can alleviate symptoms relapse is common
Experts often prescribe prophylactic azithromycin despite limited evidence of its benefits Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population
To address this gap we propose a double-blind randomized controlled trial to assess azithromycins effectiveness and safety in preventing respiratory infections in children with these conditions This research aims to inform clinical practice and improve the health of affected children and their families
The link between these conditions and persistent bacterial bronchitis remains unclear possibly due to compromised airways and reduced mucociliary clearance Although antibiotics can alleviate symptoms relapse is common
Experts often prescribe prophylactic azithromycin despite limited evidence of its benefits Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population
To address this gap we propose a double-blind randomized controlled trial to assess azithromycins effectiveness and safety in preventing respiratory infections in children with these conditions This research aims to inform clinical practice and improve the health of affected children and their families
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None