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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TYGACIL
• Medical condition to be studied:
  Skin infection

  Abdominal infection

Population studied

• Short description of the study population:
  Patients with complicated intra-abdominal infection or complicated skin and soft tissue infection treated with Tygacil at any dose and for any indication within selected hospitals or wards between February 2010 and February 2011 and between February 2012 and February 2013.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Intra-abdominal infection (cIAI) and complicated skin or soft tissue infection (cSSTI)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The main objective of this study is to assess the effectiveness of recently implemented Tygacil Risk Minimization Measures (RMM) by describing indications for Tygacil use, and to describe clinical outcomes among adult patients with cIAI or cSSTI treated with approved doses of Tygacil in the EU before and after implementation of the RMM.
• Outcomes:
  1) Indication for Tygacil use defined as the infection type which Tygacil is prescribed to treat, 2) Superinfection and lack of efficacy throughout the duration of Tygacil treatment at approved doses for approved indications. Pathogen associated with the infection for which Tygacil was prescribed to treat.
• Data analysis plan:
  Indication for Use: Distribution of indications for Tygacil will be analyzed overall and stratified by study period (pre- vs. post-RMM). Proportion of off-label use and its 95% confidence interval (CI) will be estimated for pre- and post-RMM periods. Off- and on-label users of Tygacil will be described in terms of patient characteristics (demographics, comorbidities, prior antibiotic therapy and surgical procedures, etc.) and treatment characteristics (Tygacil monotherapy vs. combination therapy, dose, duration of treatment, etc.). No Statistical inferences will be made.Superinfection and Lack of Efficacy: Incidence proportions and associated 95% CI for superinfection and lack of efficacy will be estimated separately for patients treated with approved doses of Tygacil for cIAI and cSSTI. Incidence estimates will be stratified as data allows by disease severity, Tygacil monotherapy or combination therapy, Tygacil duration, and other potential confounding factors.

Documents

Study results

b1811184-abstract_disclosed

B1811184_STUDYREPORT_FINAL_16SEP2014_disclose_Redacted

Study report

B1811184_STUDYREPORT_FINAL_16SEP2014_disclose part 2