Treat Infections in Neonates 2

• Register: EUCTR
• Last refreshed on: 27 June 2016
• Main ID: EUCTR2013-003889-14-HU
• Date of registration: 11/12/2014
• Prospective Registration: No
• Primary sponsor: Institut National de la Santé et de la Research Médicale
• Public title: Treat Infections in Neonates 2
• Scientific title: A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants - TINN2
• Date of first enrolment: 09/12/2014
• Target sample size: 810
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003889-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Hungary

Contacts

• Name: Sonia GUEGUEN
• Affiliation: Inserm

• Name: Sonia GUEGUEN
• Affiliation: Inserm

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Bronchopulmonary Dysplasia
MedDRA version: 17.1 Level: PT Classification code 10006475 Term: Bronchopulmonary dysplasia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1 Level: LLT Classification code 10066204 Term: Chronic lung disease of prematurity System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Azithromycin
Product Name: Azithromycin
Pharmaceutical Form: Lyophilisate for solution for infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 36 weeks postmenstrual age

Main Objective: To assess the efficacy azithromycin on the rate of survival without CLD 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 of CLD according to NIH definition; Pulmonary colonisation by Ureaplasma spp.; Duration of positive pressure respiratory support; Inflammatory markers in bronchoalveolar lavage; Microbiological markers including Ureaplasma spp, Mycoplasma spp; Resistance to azithromycin in Ureaplasma; Resistance to azithromycin among microbes isolated from stool or rectal swab; Exposure to supplemental antibiotics; Development of complications of prematurity; Safety and tolerability assessment; Pharmacokinetics; Respiratory, neurological and cognitive development the corrected age of 24 months

Primary end point(s): Chronic Lung disease or Death

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. 28 days of life; 36 weeks postmenstrual age; 2 years of life
2. 36 weeks postmenstrual age
3. Baseline, days 5/10/21 following first dose
4. Discharge from hospital
5. Baseline, days 5/10/21 following first dose
6. Baseline, day 21 following first dose
7. Baseline, day 21 following first dose
8. Until discharge from hospital
9. Until discharge from hospital
10. Until discharge from hospital
11. Days 1, 3 and 5 following first dose
12. 24 months corrected age

Secondary end point(s): 1. Mortality
2. Severity of CLD according to NIH definition
3. Pulmonary colonisation by Ureaplasma spp.
4. Duration of positive pressure respiratory support
5. Inflammatory markers in bronchoalveolar lavage
6. Resistance to azithromycin in Ureaplasma
7. Resistance to azithromycin among microbes isolated from stool or rectal swab
8. Exposure to supplementary antibiotics
9. Development of complications of prematurity
10. Safety and tolerability
11. Pharmacokinetics
12. Respiratory, neurological and cognitive measurements

Secondary ID(s)

C12-75

Source(s) of Monetary Support

European Commission 7th Framework Programme