Prospective, observational cohort, evaluating the incidence of nephrotoxicity, and other adverse events of interest, in patients treated with the higher recommended teicoplanin loading dose (12 mg/kg twice a day), and comparison with external historical comparator data (OBS13842)

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

  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Antibiotic therapy

Population studied

• Short description of the study population:
  The study population: adults, aged 18 years or older, with infection types for which the higher loading dose of teicoplanin is approved (as per SmPC) and for whom the treating physician intends to prescribe teicoplanin loading dosage 12 mg/kg twice a day.; Inclusion criteria; • Adult patients (aged 18 years or older), with infection types for which the higher loading dose of teicoplanin is approved (as per SmPC), who are prescribed teicoplanin loading doses of 12 mg/kg twice a day by the treating physician.; • Agree to participate and sign the ICF (signed by the patient or by the patient’s representative).; Exclusion criteria; • Age less than 18 years on the date of inclusion.; • Patients with a history of hypersensitivity to teicoplanin (or to any of the excipients listed in SmPC or to vancomycin.
• 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:
  300

Study design details

• Main study objective:
  The primary objective is to determine the incidence of nephrotoxicity reported in association with teicoplanin higher loading doses of 12 mg/kg twice a day, over the loading dose period up to day10.
• Outcomes:
  The primary objective is to determine the incidence of nephrotoxicity reported in association with teicoplanin higher loading doses of 12 mg/kg twice a day, over the loading dose period up to day10. Nephrotoxicity during the maintenance period and the entire study period, Hepatotoxicity, Thrombocytopenia, Hearing and balance/vestibular disorders, renal failure, dialysis and renal replacement therapy, Adverse events/reactions
• Data analysis plan:
  The primary analysis is the incidence of nephrotoxicity over the loading dose period up to day -10 will be computed with exact binomial 95% confidence interval. Multiple occurrences of nephrotoxicity in the same patient will be counted only once. A logistic regression will be performed to evaluate covariates associated with the development of selected events. An additional sensitivity analysis will be performed to evaluate the influence of covariates on the occurrence of nephrotoxicity, with known risk factors of nephrotoxicity forced in the model.