Treatment outcomes from Retrospective Analysis of patient Charts for AztrEonam/Avibactam (TRACE)  

Study type

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

  Healthcare resource utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-only

Study drug and medical condition

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

  AVIBACTAM
• Anatomical Therapeutic Chemical (ATC) code:
  (J01DF51) aztreonam and beta-lactamase inhibitor

  aztreonam and beta-lactamase inhibitor
• Medical condition to be studied:
  Infection
• Additional medical condition(s):
  To estimate the clinical cure rate (proportion) of hospitalized adult patients receiving ATM-AVI for infections caused by multi-drug-resistant Gram-negative organisms.

Population studied

• Short description of the study population:
  Indication for antibiotic use: Individual ≥18 years of age, hospitalized with a suspected or documented Gram-negative bacterial infection , and received ATM-AVI for at least 72 hours ; ; Microbiological sampling: Patient underwent microbiological sampling prior to or on the same day of initiation of ATM-AVI ; ; Treatment timeline: Record of receiving ATM-AVI treatment between September 1, 2024, or the earliest date ATM-AVI is commercially available in each country, and October 31, 2027.
• 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)

Study design details

• Study design:
  This study is a non-interventional, exposure-based retrospective chart review intended to describe patient characteristics and real-world clinical outcomes associated with ATM-AVI use in hospitalized adults.
• Main study objective:
  To estimate the clinical cure rate (proportion) of hospitalized adult patients receiving ATM-AVI for infections caused by multi-drug-resistant Gram-negative organisms.
• Setting:
  This study is an international study intended to be conducted in selected hospitals/sites in Europe and Saudi Arabia based on the results of feasibility assessment performed between July and December 2025. This assessment provided important insights into the feasibility of the planned study to describe real-world clinical outcomes associated with ATM-AVI in adult patients with Gram-negative bacterial infections.
• Outcomes:
  Patient demographics, clinical history, comorbidities, index infection characteristics, microbiological results, ATM-AVI use patterns, clinical cure/failure, healthcare resource utilization including length of stay (LOS), Intensive Care Unit (ICU) LOS, and readmissions within 30 days, in hospital all cause mortality
• Data analysis plan:
  Continuous variables will be summarized using descriptive statistics such as number of observations (N), mean, SD, median, first and third quartile, minimum and maximum values. Categorical data will be summarized with the N and percentage (%) of patients in each category. Missing observations will be presented in tables as a separate category. The calculation of percentages will not include the missing category. Missing values in this study will not be imputed. All statistical tests performed are 2-sided with a significance level of 5%. No adjustment for multiple ; testing is performed. Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a SAP which will be dated, filed and maintained by the sponsor. The SAP may modify ; the plans outlined in the protocol; any major modifications of primary endpoint definitions or their analyses would be reflected in a protocol amendment. For primary endpoint, the frequency and proportion of clinical cure will be calculated. The Clopper Pearson exact method will be used to calculate the 95% confidence interval. For the secondary and exploratory endpoints, descriptive summary will be performed as appropriate. Survival analysis using the Kaplan–Meier method will be applied for time-to-event outcomes (e.g. mortality and cure), accounting for differing follow-up times and censoring. Cox proportional hazards regression will be conducted to analyze the impact of multiple covariates (e.g., antimicrobial genotypic/phenotypic resistance, specific pathogens, infection sites, potential risk factors for resistance and marker of disease severity) on the time it takes for mortality or cure. The first dose of ATM-AVI therapy will be defined as time 0 for survival analysis.