Post-Marketing Study to Assess the Effectiveness and Safety of RECARBRIO in Chinese Adult Patients With Limited or No Alternative Treatment Options for Susceptible Gram-Negative Bacterial Infections (MK-7655A-035)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  RECARBRIO
• Study drug International non-proprietary name (INN) or common name:
  IMIPENEM

  CILASTATIN SODIUM

  RELEBACTAM
• Anatomical Therapeutic Chemical (ATC) code:
  (J01DH56) imipenem, cilastatin and relebactam

  imipenem, cilastatin and relebactam
• Additional medical condition(s):
  Hospital-Acquired Bacterial Pneumonia and Ventilator- Associated Bacterial Pneumonia; Complicated Urinary Tract Infection; Complicated Intra-Abdominal Infection

Population studied

• Short description of the study population:
  Chinese patients aged 18 years or older who have received at least one dose of RECARBRIO for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP), Complicated Intra-Abdominal Infection (cIAI), or Complicated Urinary Tract Infection (cUTI) (including pyelonephritis) with limited or no alternative treatment options and meet all study inclusion and exclusion criteria.
• Age groups:
  • 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:
  140

Study design details

• Study design:
  This is a multicenter, non-interventional cohort study with a hybrid design incorporating both retrospective and prospective data collection. Data will be obtained primarily through chart review at participating sites using a standardized Case Report Form (CRF).
• Main study objective:
  To evaluate the real-world effectiveness of RECARBRIO (imipenem/cilastatin/relebactam) in Chinese adult patients with limited or no alternative treatment options for susceptible Gram-negative bacterial infections—including hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), complicated urinary tract infections (cUTI, including pyelonephritis), and complicated intra-abdominal infections (cIAI)—by estimating separately the proportion of patients achieving a favorable clinical response at the test of cure (TOC) and end of treatment (EOT) visits.
• Setting:
  Chinese adult patients with limited or no alternative treatment options for susceptible Gram-negative bacterial infections—including HABP/VABP, cUTI including pyelonephritis and cIAI.
• Comparators:
  A non-comparative, single-arm framework will be employed, with no external comparator group included in the study. Comparisons are limited to within-cohort outcome assessments across specified evaluation timepoints with all analyses conducted descriptively in this real-world population.
• Outcomes:
  The primary outcomes are favorable clinical response (clinical cure) to RECARBRIO for the index infection, assessed separately at the TOC and EOT visits, in the overall study population who have received at least 3 days of RECARBRIO for the treatment of cIAI or cUTI (including pyelonephritis) with limited or no alternative treatment options. Clinical cure is defined as the complete resolution or significant improvement of signs and symptoms of the index infection.
• Data analysis plan:
  Descriptive statistical methods will be used to summarize study data, and no formal hypothesis testing will be performed. Patient attrition, patient characteristics, treatment patterns, and effectiveness outcomes of; interest will be described using frequency and percentage distributions for categorical variables, and mean, standard deviation (SD), median, interquartile range (IQR), minimum, and maximum for continuous variables.