A Post-marketing, Observational Safety Study of Quinsair (Levofloxacin Hemihydrate) in Patients with Cystic Fibrosis [CLI-LEVFLAA1-01]

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  QUINSAIR
• Medical condition to be studied:
  Cystic fibrosis lung

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  800

Study design details

• Main study objective:
  To evaluate the safety profile of Quinsair over a 5-year period (2017-2021) compared to other inhaled approved antibiotic therapies in CF patients who are enrolled in the UK CF Registry. The main objective has been enlarged with a 3-year (2019-2021) period observation in CF patients who are enrolled in the German CF Registry
• Outcomes:
  The occurrence of each AESI: haemotysis, hepatotoxicity, tendon rupture. Discontinuation of Quinsair and other inhaled approved antibiotic therapies due to AEs Patterns of antimicrobial resistance of P. aeruginosa isolated from Quinsair-treated patients, The occurrence of musculoskeletal events (including arthritis, arthropathy, tendinitis, other tendinopathy, tendon rupture) in patients < 18 years of age who are using Quinsair off-label.
• Data analysis plan:
  Descriptive statistics will be produced for each indicated parameter. For continuous data, the number of observations, mean, standard deviation, median, min and max will be presented. Data will be evaluated for the presence of likely effect modifiers and confounding factors in univariate analyses. Summary and descriptive statistics for demographic and baseline characteristics will be presented for each of the cohorts. Two methods for adjusting for confounders may be used depending on sample and data availability: - Matching of treatment according to propensity scores - reweighting using inverse propensity scores weighting (IPW) as part of marginal structural models. Analyses of primary & secondary endpoints: - AESIs in adult CF patient: Number and % of patients reporting each AESI will be summarized with crude RR and 95% CI, incidence rates for each event and time-to-event analyses in both cohorts. - occurrence of musculoskeletal events in patients <18 years of age