A Post-Authorization Safety Study of the Use of Intravenous Telavancin (VIBATIV®) in the Clinical Setting (Telavancin PASS)

Study identification

• EU PAS number:
  EUPAS9669
• Study ID:
  9670
• Official title and acronym:
  A Post-Authorization Safety Study of the Use of Intravenous Telavancin (VIBATIV®) in the Clinical Setting (Telavancin PASS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  Cyprus

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Isle of Man

  Italy

  Latvia

  Liechtenstein

  Lithuania

  Luxembourg

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Slovenia

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a retrospective chart review of patients who have been treated with telavancin (follow-up 6 months post-treatment) in the European Economic Area.
• Study status:
  Planned

Research institutions and networks

Institutions

Clinigen Group

Study timelines

Date when funding contract was signed

Planned:26/06/2015

Study start date

Planned:30/09/2015

Data analysis start date

Planned:11/03/2016

Date of interim report, if expected

Planned:11/09/2016

Date of final study report

Planned:31/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Clinigen Group plc

Regulatory

• Was the study required by a regulatory body?:
  Yes