Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40850
• EU PAS number:
  EUPAS21359
• Study ID:
  40850
• Official title and acronym:
  Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Greece

  Netherlands

  Romania
• Study description:
  A systematic literature review of all available treatment guidelines and recommendations and the evidence behind them, and a European cross-sectional six-country survey of antibiotic prescribing patterns and algorithms used in clinical practice. As added values, we will include an MDR treatment outcome analysis using existing Danish data and, if accessible, other European individual-level hospital data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Networks

Aarhus University Consortium (ad hoc)

Study timelines

Date when funding contract was signed

Planned: 17/03/2017

Actual: 17/03/2017

Study start date

Planned: 17/06/2017

Actual: 17/06/2017

Date of final study report

Planned: 17/11/2018

Actual: 12/10/2018

Sources of funding

EMA

Study protocol

Initial protocol

Animicrobal resistance

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable