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 - Respi
Conditions
Interventions
Trade Name: Azithromycin
Product Name: Azithromycin
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: azithromycin
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of azithromycin in increasing survival without physiologically defined CLD (moderate/severe) when compared to placebo; Secondary Objective: 1) To determine the effect of azithromycin on mortality rate (at 36 weeks’ postmenstrual age) 2) To determine the effectiveness of azithromycin in reducing duration of respiratory support 3) To determine the safety and tolerability of azithromycin 4) To determine if azithromycin alters resistance to macrolides amongst Streptococcus and Staphylococcus spp microbes isolated from respiratory and stool samples In Ureaplasma positive infants only 5) To investigate if colonisation with Ureaplasma spp. prior to randomisation modifies the treatment effect of azithromycin compared to placebo ; Primary end point(s): 1) Death 2) Physiologically defined CLD at 36 weeks’ postmenstrual age ;Timepoint(s) of evaluation of this end point: 36 weeks postmenstrual age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) Death B) Number of days of respiratory support required: 1) conventional mechanical ventilation/HFOV 2) continuous positive airway pressure 3) high flow nasal cannula 4) number of days of oxygen dependency C) Development of Complications of Prematurity 1) Nosocomial infection (line- sepsis, meningitis, pneumonia); confirmed microbiologically or antibiotic treatment for 5 days or more 2) severe intraventricular haemorrhage (grade III/IV) 3) necrotising enterocolitis (Bell stage II and above) 4) treatment for retinopathy of prematurity 5) treatment for patent ductus arteriosus 6) Serious adverse events/reactions Following any unexpected and unexplained arrhythmias on routine heart rate monitoring, formal ECG will be obtained to assess QTc interval with follow up ECG 10 days after stopping treatment. D) Resistance to macrolides among microbes isolated from respiratory and stool samples ; Timepoint(s) of evaluation of this end point: A) 36 weeks postmenstrual age B) Discharge from hospital C) Until 36 weeks’ postmenstrual age, or discharge home from hospital (whichever is soonest D) Up to 21 days of life | — |
Countries
United Kingdom
Contacts
Public ContactResearch Governance Team
Cardiff University
Outcome results
None listed