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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

  Drug utilisation

Study drug and medical condition

• Name of medicine:
  VIBATIV
• Medical condition to be studied:
  Staphylococcal infection

Population studied

• 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)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective of this study is to assess changes in renal function during and after treatment with telavancin. Adverse Events (AEs) received will be followed up and all efforts will be made to follow up Serious Adverse Events (SAEs) for at least 6 months from first administration of telavancin. Any fatal AE/SAEs will be followed up to collect as much information as possible.
• Outcomes:
  To investigate the risks of the following endpoints in order to further characterize the safety of telavancin with respect to renal disorders. The frequency of renal impairment will be investigated, serum creatinine greater than 50% above baseline, serum creatinine greater than 100% above baseline, urine output, need for renal replacement therapy, classification according to RIFLE criteria. Appropriate reporting of all events of special interest, adherence to the SmPC, appropriate usage of the pregnancy sticker and pregnancy testing prior to dosing.
• Data analysis plan:
  All demographic, efficacy and safety variables will be summarised using descriptive statistics and graphs as appropriate. Continuous variables will be summarised by mean, SD, median, minimum, maximum and number of patients. Categorical variables will be summarized using frequency tabulations. Individual data will be presented in patient listings. Medical history and prior and concurrent medications will be summarised and listed. AEs will be classified using the MedDRA classification system. The simple frequency and rate per patient-unit time of AEs will be tabulated by System Organ Class (SOC) and MedDRA Preferred Term. SAEs (including those defined in Section 5.5 of the protocol), AEs leading to discontinuation of telavancin and AEs leading to death will be listed and summarised separately, again by SOC and Preferred Term. Time to first occurrence of a given AE, time to discontinuation due to AE and time to death will be summarised graphically by Kaplan-Meier curves.