NCT02282176

Brief Summary

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

Trial Health

37
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for phase_3

Geographic Reach
9 countries

16 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

October 17, 2014

Last Update Submit

February 24, 2016

Conditions

Bronchopulmonary Dysplasia

Keywords

NeonatesPretermAzithromycinUreaplasmaChronic Lung diseaseBronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

  • The proportion of surviving infants without CLD (Chronic Lung Disease) in the azithromycin treatment group when compared to placebo at 36 weeks post-menstrual age.

    36 weeks post-menstrual age

Secondary Outcomes (15)

  • Mortality rate (at 28 days, 36 weeks PMA, 2 years)

    28 days, 36 weeks PMA, 2 years

  • Severity of CLD (Chronic Lung Disease) according to NIH definition

    36 weeks PMA

  • Microbiology assessment

    Baseline and days 5, 10, 21

  • Inflammation Markers

    Baseline and days 5, 10, 21

  • Duration of positive pressure respiratory support (i.e. conventional mechanical ventilation, nasal ventilation, continuous positive airway pressure, CPAP) and supplemental oxygen

    up to 36 weeks PMA

  • +10 more secondary outcomes

Study Arms (2)

Azithromycin

EXPERIMENTAL

10mg/kg azithromycin IV daily (administered over a period of at least one 1 hour) for a period of 10 days.

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Placebo IV daily (administered over a period of at least one 1 hour) for a period of 10 days.

Drug: Placebo

Interventions

AzithromycinDRUG

Azithromycin IV 10mg/kg daily for 10 days

Azithromycin
PlaceboDRUG

Azithromycin placebo (5% Dextrose) daily for 10 days

Also known as: 5% Dextrose
Placebo

Eligibility Criteria

Age23 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pre-term, 28w + 6d gestational age (i.e. 28 weeks and 6 days, including infants born as one of a multiple birth)
  • Requirement for respiratory support within 12hrs of birth (intubated, or by noninvasive mechanical ventilation including continuous positive airway pressure)
  • Presence of an indwelling intravenous line for drug administration
  • Inborn, or born at site within the recruiting centre's neonatal network where follow up will be possible

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Centre Hospitalier Chrétien (CHC)

Liège, Belgium

Location

Assistance Publique Hôpitaux de Paris (APHP)

Paris, France

Location

Inserm-Transfert (IT)

Paris, France

Location

Institut National de la Santé et de la Recherche Médicale (INSERM)

Paris, France

Location

Only for children pharmaceuticals (04CP)

Paris, France

Location

Heinrich-Heine-Universität Düsseldorf (UDUS)

Düsseldorf, Germany

Location

University of Ulm (UUlm)

Ulm, Germany

Location

Semmelweis University Budapest, Faculty of Medicine (SOTE)

Budapest, Hungary

Location

Pandy Kalman County Hospital

Gyula, Hungary

Location

Mario Negri Institute (IRFMN)

Milan, Italy

Location

Advanced Biological Laboratories ABL (ABL SA)

Luxembourg, Luxembourg

Location

Erasmus-University Medical Center (ERAMUS)

Rotterdam, Netherlands

Location

Karolinska Institutet (KI)

Stockholm, Sweden

Location

Cardiff University (CU)

Cardiff, United Kingdom

Location

University of Liverpool (UOL)

Liverpool, United Kingdom

Location

Simcyp Limited (SimCyp)

Sheffield, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 21697219BACKGROUND

  • 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.

    PMID: 24518104BACKGROUND

  • 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.

    PMID: 24445836BACKGROUND

Related Links

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Interventions

AzithromycinGlucose

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Sailesh Kotecha

    Cardiff University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

November 4, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

BE(1)FR(4)HU(2)GB(3)IT(1)SE(1)LU(1)DE(2)NL(1)