drugset / Trial / NCT02282176
TINN2: Treat Infection in NeoNates 2
Phase 3
Withdrawn
French National Institute of Health and Medical Research
Advanced Biological Laboratories ABL (ABL SA) · collabAssistance Publique - Hôpitaux de Paris · collabCardiff University · collabCentre Hospitalier Chrétien (CHC) · collabErasmus Medical Center · collabHeinrich-Heine-Universität Düsseldorf (UDUS) · collabKarolinska Institutet · collabMario Negri Institute (IRFMN) · collabOnly For Children Pharmaceuticals · collabSemmelweis University · collabSimcyp Limited (SimCyp) · collabUniversity of Liverpool · collabUniversity of Nottingham · collabUniversity of Ulm · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
Timeline
- Start
- 2015-01
- Primary completion
- 2017-01
- Completion
- 2018-01
Publications
- Background Turner MA, Jacqz-Aigrain E, Kotecha S. Azithromycin, Ureaplasma and chronic lung disease of prematurity: a case study for neonatal drug development. Arch Dis Child. 2012 Jun;97(6):573-7. doi: 10.1136/adc.2010.195180. Epub 2011 Jun 22.
- Background Pansieri C, Pandolfini C, Elie V, Turner MA, Kotecha S, Jacqz-Aigrain E, Bonati M. Ureaplasma, bronchopulmonary dysplasia, and azithromycin in European neonatal intensive care units: a survey. Sci Rep. 2014 Feb 12;4:4076. doi: 10.1038/srep04076.
- Background Lowe J, Watkins WJ, Edwards MO, Spiller OB, Jacqz-Aigrain E, Kotecha SJ, Kotecha S. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis. Pediatr Infect Dis J. 2014 Jul;33(7):697-702. doi: 10.1097/INF.0000000000000239.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 10 mg/kg | Intravenous |