A post-marketing database surveillance to investigate the risk of diagnosed myelosuppression events in MRSA patients treated with tedizolid or linezolid in Japan (MK-1986-045)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SIVEXTRO

  LINEZOLID
• Study drug International non-proprietary name (INN) or common name:
  TEDIZOLID PHOSPHATE
• Anatomical Therapeutic Chemical (ATC) code:
  (J01XX08) linezolid

  linezolid

  (J01XX11) tedizolid

  tedizolid
• Medical condition to be studied:
  Myelosuppression

Population studied

• Short description of the study population:
  The study population is MRSA patients who were treated with tedizolid or linezolid between 21-Aug-2018 and 31-Mar-2025 in Japan.; ; Key inclusion criteria include:; 1. Has a new prescription date (index date) for tedizolid or linezolid during the cohort entry period 21-Aug-2018 to 31-Mar-2025.; 2. Confirmed diagnosis of MRSA and confirmed diagnosis of indications for both tedizolid and linezolid in the same month or previous month of the index date.; ; Key exclusion criteria include:; 1. Do not have 60 days lookback period prior to the index date.; 2. Have prescriptions for both tedizolid and linezolid on the same index date.; 3. Have one or more events of myelosuppression within 14 days prior to the index date.; 4. Have prescription records for tedizolid or linezolid only on the index date.; 5. Have a diagnosis of hematological diseases (such as myelodysplastic syndrome, aplastic anemia, and immune thrombocytopenia) within lookback period.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Study design:
  This is an observational cohort study with active comparator new user design, using MID-NET. The study will be conducted using only structured secondary data.
• Main study objective:
  The main objective is to compare the risk of diagnosed myelosuppression between those patients taking tedizolid and those patients taking linezolid for MRSA.
• Setting:
  The study population is MRSA patients who were treated with tedizolid or linezolid between 21-Aug-2018 and 31-Mar-2025 in Japan. The study will be conducted using only structured secondary data collected from MID-NET.
• Comparators:
  The group of patients who are newly prescribed/exposed to tedizolid during the cohort entry period (21-Aug-2018 to 31-Mar-2025) will be considered as the tedizolid group. The group of patients who newly start linezolid during the cohort entry period (21-Aug-2018 to 31-Mar-2025) will be considered as the linezolid group.
• Outcomes:
  The outcome of interest in the study is myelosuppression. Myelosuppression is defined as following.; Meeting or exceeding Grade 2 or higher by CTCAE Version 5.0 criteria for any of the following items:; Decreased white blood cells, decreased platelets, decreased neutrophils, anemia (decreased hemoglobin).
• Data analysis plan:
  Incidence rates of myelosuppression and binomial confidence intervals will be calculated descriptively for tedizolid and linezolid groups separately. The number and percentage of myelosuppression will be calculated based on myelosuppression test items and grades. For all patients, the exposure time starts the day after the initiation of treatment date. If there are 10 or more events observed for each treatment group, crude odds ratios and 95% CI will be estimated using logistic regression models, to compare the risk of myelosuppression between the tedizolid group and linezolid group. Basic statistics on the surveillance population will be presented as n (%), mean ± standard deviation (SD), or median (interquartile range [IQR]), as appropriate.