WP6 replication study: The risk of liver injury associated with the use of antibiotics: A study using a US database with linkage with hospital data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28271
• EU PAS number:
  EUPAS2999
• Study ID:
  28271
• Official title and acronym:
  WP6 replication study: The risk of liver injury associated with the use of antibiotics: A study using a US database with linkage with hospital data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 02/02/2012

Actual: 02/02/2012

Study start date

Planned: 02/04/2012

Actual: 02/04/2012

Data analysis start date

Planned: 01/05/2012

Actual: 01/05/2012

Date of final study report

Planned: 31/12/2013

Actual: 17/04/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable