Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2015-01-31
2018-01-31
Brief Summary
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Detailed Description
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The new Paediatric Regulation entered into force in early 2007 ensure that medicines for use in children are of high quality, ethically evaluated and authorised appropriately. The Paediatric-Use Marketing Authorisation (PUMA) is a new type of marketing authorisation for drugs not covered by a patent, already available on the market for adults. PUMA applies to medicines lacking information and/or appropriate formulation for children of all ages.
Thus, the European Medicines Agency (EMA) has published a list of drugs, which azithromycin belongs, as priority medicinal products needing an evaluation in the paediatric population.
Bronchopulmonary dysplasia (BPD) is a specific disease of prematurity accompanied by pulmonary inflammation. Multiple factors may contribute to the occurrence of BPD. In infants who are at risk of developing CLD, one frequent finding is colonisation of the preterm lung with the microbe Ureaplasma.
Two Meta-Analyses and recent studies have suggested an association between the presence of pulmonary Ureaplasma and the development of BPD.
Azithromycin is a macrolide antibiotic active against Ureaplasma spp with anti-inflammatory properties. Thus, it may be effective in reducing the severity of bronchopulmonary diseases in which both infection and inflammation play a role.
TINN2 project: the aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates. TINN2 is a consortium involving European leaders in neonatology, paediatric pharmacology, methodology and several SMEs that will establish links with ethical bodies and regulatory authorities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Azithromycin
10mg/kg azithromycin IV daily (administered over a period of at least one 1 hour) for a period of 10 days.
Azithromycin
Azithromycin IV 10mg/kg daily for 10 days
Placebo
Placebo IV daily (administered over a period of at least one 1 hour) for a period of 10 days.
Placebo
Azithromycin placebo (5% Dextrose) daily for 10 days
Interventions
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Azithromycin
Azithromycin IV 10mg/kg daily for 10 days
Placebo
Azithromycin placebo (5% Dextrose) daily for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
23 Weeks
28 Weeks
ALL
No
Sponsors
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University of Liverpool
OTHER
Cardiff University
OTHER
University of Nottingham
OTHER
Erasmus Medical Center
OTHER
Heinrich-Heine-Universität Düsseldorf (UDUS)
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Mario Negri Institute (IRFMN)
UNKNOWN
Advanced Biological Laboratories ABL (ABL SA)
UNKNOWN
Simcyp Limited (SimCyp)
UNKNOWN
Only For Children Pharmaceuticals
INDUSTRY
University of Ulm
OTHER
Karolinska Institutet
OTHER
Centre Hospitalier Chrétien (CHC)
UNKNOWN
Semmelweis University
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Sailesh Kotecha
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Locations
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Centre Hospitalier Chrétien (CHC)
Liège, , Belgium
Assistance Publique Hôpitaux de Paris (APHP)
Paris, , France
Inserm-Transfert (IT)
Paris, , France
Institut National de la Santé et de la Recherche Médicale (INSERM)
Paris, , France
Only for children pharmaceuticals (04CP)
Paris, , France
Heinrich-Heine-Universität Düsseldorf (UDUS)
Düsseldorf, , Germany
University of Ulm (UUlm)
Ulm, , Germany
Semmelweis University Budapest, Faculty of Medicine (SOTE)
Budapest, , Hungary
Pandy Kalman County Hospital
Gyula, , Hungary
Mario Negri Institute (IRFMN)
Milan, , Italy
Advanced Biological Laboratories ABL (ABL SA)
Luxembourg, , Luxembourg
Erasmus-University Medical Center (ERAMUS)
Rotterdam, , Netherlands
Karolinska Institutet (KI)
Stockholm, , Sweden
Cardiff University (CU)
Cardiff, , United Kingdom
University of Liverpool (UOL)
Liverpool, , United Kingdom
Simcyp Limited (SimCyp)
Sheffield, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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2013-003889-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C12-75
Identifier Type: -
Identifier Source: org_study_id
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