Optimizing patient recruitment into clinical trials of antimicrobial-resistant pathogens

Mical Paul, Yael Dishon-Benattar, Yaakov Dickstein, Dafna Yahav

Research output: Contribution to journalReview articlepeer-review

Abstract

Recruitment of patients with critical priority antimicrobial-resistant (AMR) bacteria into drug approval randomized controlled trials (RCTs) has not been successful to date. Approaching from the viewpoint of clinician-investigators and learning from the experience of AMR-focused investigator-initiated trials, we present suggestions to improve feasibility and efficiency of RCTs evaluating patients with severe infections caused by carbapenem-resistant Gram-negative or other AMR bacteria. Considerations address the trials' eligibility criteria, whether the focus of the trial is pathogen- or syndrome-targeted, trials' case report forms and monitoring, informed consent strategies for the recruitment of extremely ill patients, team dedication and incentives to run the trial and alternative trial designs. Evidence on the effects of new drugs against the AMR that these drugs target is weak and needs to be improved through better industry-academic collaboration, taking advantage of the different strengths of industry-led and investigator-initiated research.

Original languageEnglish
Article numberdlad005
JournalJAC-Antimicrobial Resistance
Volume5
Issue number1
DOIs
StatePublished - 1 Feb 2023

Bibliographical note

Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases
  • Immunology and Allergy
  • Microbiology
  • Immunology

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