TINN2: Treat Infection in NeoNates 2

Summary

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

Conditions

• Bronchopulmonary Dysplasia

Interventions

DRUG

Azithromycin

Azithromycin IV 10mg/kg daily for 10 days

DRUG

Placebo

Azithromycin placebo (5% Dextrose) daily for 10 days

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Cardiff University

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Heinrich-Heine-Universität Düsseldorf (UDUS)

  collaborator UNKNOWN

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Mario Negri Institute (IRFMN)

  collaborator UNKNOWN

• Advanced Biological Laboratories ABL (ABL SA)

  collaborator UNKNOWN

• Simcyp Limited (SimCyp)

  collaborator UNKNOWN

• Only For Children Pharmaceuticals

  collaborator INDUSTRY

• University of Ulm

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Centre Hospitalier Chrétien (CHC)

  collaborator UNKNOWN

• Semmelweis University

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Sailesh Kotecha · Cardiff University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

28 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-01-31

Completion

2018-01-31

Countries

• Belgium
• France
• Germany
• Hungary
• Italy
• Luxembourg
• Netherlands
• Sweden
• United Kingdom

Study Locations