Treat Infections in Neonates 2

Phase 1

Conditions: Bronchopulmonary Dysplasia
MedDRA version: 17.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1Level: LLTClassification code 10066204Term: Chronic lung disease of prematuritySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-003889-14-DE

Lead Sponsor: Institut National de la Santé et de la Research Médicale

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 810

Inclusion Criteria

a) Pre-term, =28 weeks gestational age (i.e. 28 weeks and 6 days,
including infants born as one of a multiple birth)
b) Requirement for respiratory support within 12hrs of birth (intubated,
or by non-invasive mechanical ventilation inc. continuous positive airway
pressure)
c) Presence of an indwelling intravenous line for drug administration
d) Inborn, or born at site within the recruiting centre's neonatal network
where follow up will be possible
Are the trial subjects under 18? yes
Number of subjects for this age range: 810
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) In the opinion of the PI, babies unlikely to survive until 48 hours after
birth
b) Exposure to another macrolide antibiotic
c) Presence of major surgical or congenital abnormalities (not including
patent ductus arteriosus or patent foramen ovale)
d) Infants born as part of a multiple pregnancy of three or more (i.e.
triplets or more)
e) Participation in other clinical trials involving IMPs

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy azithromycin on the rate of survival without CLD<br>in preterm infants of =28 weeks (28+6) gestation;Secondary Objective: Mortality rate at 28 days of life, 36 weeks PMA, 2 years of life ; Severity<br>of CLD according to NIH definition; Pulmonary colonisation by<br>Ureaplasma spp.; Duration of positive pressure respiratory support;<br>Inflammatory markers in bronchoalveolar lavage; Microbiological<br>markers including Ureaplasma spp, Mycoplasma spp; Resistance to<br>azithromycin in Ureaplasma; Resistance to azithromycin among microbes<br>isolated from stool or rectal swab; Exposure to supplemental antibiotics;<br>Development of complications of prematurity; Safety and tolerability<br>assessment; Pharmacokinetics; Respiratory, neurological and cognitive<br>development the corrected age of 24 months;Primary end point(s): Chronic Lung disease or Death;Timepoint(s) of evaluation of this end point: 36 weeks postmenstrual age

Secondary Outcome Measures