TINN2: Treat Infection in NeoNates 2

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Advanced Biological Laboratories ABL (ABL SA); Assistance Publique - Hôpitaux de Paris; Cardiff University; Centre Hospitalier Chrétien (CHC); Erasmus Medical Center; Heinrich-Heine-Universität Düsseldorf (UDUS); Inserm-Transfert (IT); Karolinska Institutet; Mario Negri Institute (IRFMN); Only For Children Pharmaceuticals; Semmelweis University; Simcyp Limited (SimCyp); University of Liverpool; University of Nottingham; University of Ulm
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

1. Pre-term, 28w + 6d gestational age (i.e. 28 weeks and 6 days, including infants born as one of a multiple birth)

2. Requirement for respiratory support within 12hrs of birth (intubated, or by noninvasive mechanical ventilation including continuous positive airway pressure)

3. Presence of an indwelling intravenous line for drug administration

4. Inborn, or born at site within the recruiting centre's neonatal network where follow up will be possible

Exclusion Criteria:

1. In the opinion of the PI, babies unlikely to survive until 48 hours after birth

2. Exposure to another macrolide antibiotic

3. Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)

4. Infants born as part of a multiple pregnancy of three or more (i.e. triplets or more)

5. Contraindication of azithromycin as specified in the summary of characteristics of the product.

6. Participation in other clinical trials involving Investigational Medicinal Products (IMPs)