Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project

BMJ Open. 2020 Jul 31;10(7):e035460. doi: 10.1136/bmjopen-2019-035460.


Introduction: Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood.

Methods and analysis: This study will be implemented in two phases. First, a preliminary historical cohort (2017-2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020-2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence of Clostridioides difficile infection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured.

Ethics and dissemination: Ethical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number: NCT03941951; Pre-results.

Keywords: audit; bacteriology; education & training (see medical education & training); infectious diseases; microbiology.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antimicrobial Stewardship / methods
  • Antimicrobial Stewardship / standards*
  • Azabicyclo Compounds / therapeutic use
  • Ceftazidime / therapeutic use
  • Cephalosporins / therapeutic use
  • Clinical Protocols*
  • Drug Combinations
  • Humans
  • Interrupted Time Series Analysis
  • Medication Systems / standards*
  • Oxazolidinones / therapeutic use
  • Practice Patterns, Physicians' / standards*
  • Spain
  • Tazobactam / therapeutic use
  • Teicoplanin / analogs & derivatives
  • Teicoplanin / therapeutic use
  • Tetrazoles / therapeutic use


  • Azabicyclo Compounds
  • Cephalosporins
  • Drug Combinations
  • Oxazolidinones
  • T 91825
  • Tetrazoles
  • avibactam, ceftazidime drug combination
  • ceftolozane, tazobactam drug combination
  • Teicoplanin
  • dalbavancin
  • tedizolid
  • Ceftazidime
  • Tazobactam

Associated data

  • ClinicalTrials.gov/NCT03941951