NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY TO DESCRIBE USE BY INDICATION AND CLINICAL OUTCOMES AMONG PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTION OR COMPLICATED SKIN AND SOFT TISSUE INFECTION TREATED WITH TIGECYCLINE (TYGACIL®) IN THE EUROPEAN UNION

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15651
• EU PAS number:
  EUPAS3674
• Study ID:
  15651
• Official title and acronym:
  NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY TO DESCRIBE USE BY INDICATION AND CLINICAL OUTCOMES AMONG PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTION OR COMPLICATED SKIN AND SOFT TISSUE INFECTION TREATED WITH TIGECYCLINE (TYGACIL®) IN THE EUROPEAN UNION
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Greece

  Italy

  United Kingdom
• Study description:
  Background: Tygacil is an intravenously administered antibiotic indicated in the EU for treatment of complicated intra-abdominal infection (cIAI) and complicated skin or soft tissue infection (cSSTI) excluding diabetic foot infection. This retrospective medical record review study will evaluate the effectiveness of 2011 Risk Minimization Measures (RMM) aimed at reducing off-label use of Tygacil in the EU by assessing the proportion of off-label use before and after RMM implementation. Objectives: 1) Examine the distribution of indications for Tygacil use in the EU before and after RMM implementation, 2) Determine the incidence of superinfection and lack of efficacy among adult patients treated with Tygacil for cSSTI and cIAI in the EU before and after RMM implementation.Data Collection:All patients treated with Tygacil for any indication during the study period will be retrospectively identified at participating centers in 3-6 of the top-prescribing EU countries. Patient medical records will be reviewed to determine indication for Tygacil use and to identify potential superinfection and lack of efficacy cases among those treated for approved indications. A committee of external adjudicators will review all relevant medical record data from these potential cases to determine their actual status. Methods:Frequencies of indications and the proportion of off-label use of Tygacil will be calculated before and after RMM implementation. The incidence of superinfection and lack of efficacy will be calculated in pre- and post-RMM periods among adult patients treated for cIAI and cSSTI. A descriptive analysis of pathogens associated with infection treated with Tygacil will be performed where microbiology data are available. An exploratory, hypothesis-generating multivariate comparative analysis will also be conducted to assess any change in superinfection and lack of efficacy between the pre- and post-RMM implementation period among on-label Tygacil users.
• Study status:
  Finalised

Research institutions and networks

Institutions

Scientific Affairs, Outcome SARL

Switzerland

Multiple centres: 13 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 04/01/2013

Actual: 04/01/2013

Study start date

Planned: 10/06/2013

Actual: 23/05/2013

Date of interim report, if expected

Planned: 31/01/2014

Date of final study report

Planned: 30/09/2014

Actual: 16/09/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B1811184 Protocol Amendment 2 08 November 2012

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)