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

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000956
• Study ID:
  1000000956
• Official title and acronym:
  Treatment outcomes from Retrospective Analysis of patient Charts for AztrEonam/Avibactam (TRACE)
• DARWIN EU® study:
  No
• Study countries:
  France

  Greece

  Italy

  Romania

  Saudi Arabia

  Spain

  United Kingdom
• Study description:
  ATM-AVI offers broad-spectrum activity against β-lactamase-producing bacteria, including MBL producers and provides optimized ATM and AVI exposure.14,22 While clinical studies have established ATM-AVI’s pharmacokinetics/pharmacodynamics profile, effectiveness and safety, data from routine clinical practice is scarce – particularly with regards to patient characteristics and clinical outcomes.23-28 The ASSEMBLE study specifically evaluated ATM-AVI activity against MBL-producing pathogens.21 Although the study's results suggest a promising role for ATM-AVI in treating serious infections caused by MBL-producing Gram-negative bacteria,21 the study's relatively small sample size limits the generalizability of these findings. ; ; Assessing the real-world performance of ATM-AVI and understanding its utilization for approved indications are therefore critical from a public health perspective, providing insights into the drug’s performance across diverse patient populations and clinical settings and complementing findings from controlled clinical trials. This information is valuable for highlighting the therapeutic value of ATM-AVI in combatting MDR GNB infections, which pose a significant growing public health threat.29 Furthermore, understanding the specific clinical scenarios in which ATM-AVI is prescribed can directly inform healthcare policy and resource allocation, enabling public health authorities to monitor the emergence of resistance patterns and ensuring that ATM-AVI remains a viable treatment option. In summary, evaluating the real-world application of ATM-AVI is critical, as it informs clinical practice, supports effective healthcare planning and contributes to the global effort against antimicrobial resistance. This evidence gap will be addressed by conducting an international, multi-center, descriptive retrospective medical chart review to comprehensively describe the real-world clinical outcomes associated with the use of ATM-AVI in adult patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:24/03/2026

Actual:16/03/2026

Study start date

Planned:10/08/2026

Actual:16/03/2026

Data analysis start date

Planned:24/02/2028

Actual:16/03/2026

Date of interim report, if expected

Planned:31/12/2026

Actual:16/03/2026

Date of final study report

Planned:01/06/2028

Actual:16/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable