AZTEC: Azithromycin Therapy for Chronic Lung Disease of Prematurity

Phase 1

• Conditions: Bronchopulomary dysplasia; MedDRA version: 20.0 Level: LLT Classification code 10066204 Term: Chronic lung disease of prematurity System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001109-99-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 796

Inclusion Criteria

a)Gestational age =29w+6d (including infants born as one of a multiple birth)
b)Neonates who have had respiratory support for at least 2 continuous hours duration during the first 72 hours of life (intubated, or by non-invasive mechanical ventilation including continuous positive airway pressure and high flow nasal cannula or a combination thereof)
c)Presence of an indwelling intravenous line for drug administration
d)Written informed consent within 72 hours of birth at the latest
e) Anticipating administration of first dose within 72 hours of birth at the latest
f)Reasonable to expect completion of 10 days of trial treatment whilst resident at the recruiting site
g)Inborn, or born at site within the recruiting site's neonatal network where follow up will be possible
h)In the opinion of the PI, reasonable prospect of survival past the first 72 hours of life

Are the trial subjects under 18? yes
Number of subjects for this age range: 796
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a)Exposure to another systemic macrolide antibiotic (not maternal)
b)Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
c)Known contraindication of azithromycin as specified in the summary of characteristics of the product
d)Participation in other interventional trials that precludes participation in AZTEC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified