Choosing the right outcomes in infectious diseases clinical research—putting patients front and centre

In this issue of Clinical Microbiology and Infection, Stabholz and Paul [ [1] Stabholz Y. Paul M. The effect of antibiotic therapy for Clostridioides difficile infection on mortality and other patient-relevant outcomes: a systematic review and meta-analysis. Clin Microbiol Infect. 2023; S1198–743X:420–422https://doi.org/10.1016/j.cmi.2023.09.002 Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar ] present a systematic review and meta-analysis comparing vancomycin, fidaxomicin, and metronidazole for the treatment of Clostridioides difficile infection (CDI) with all-cause mortality as a primary outcome, in addition to a range of other clinically relevant and patient-relevant outcomes. This study adds further nuance to the choice between fidaxomicin and vancomycin for treatment of an initial CDI episode. Separate guidelines published in 2021 by Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) both recommended fidaxomicin over vancomycin on the basis of sustained cure without recurrence, although there was no difference in other outcomes assessed (initial clinical cure, drug-related adverse events, and all-cause mortality) [ [2] Johnson S. Lavergne V. Skinner A.M. Gonzales-Luna A.J. Garey K.W. Kelly C.P. et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 focused update guidelines on management of Clostridioides difficile infection in adults. Clin Infect Dis. 2021; 73: 755-757https://doi.org/10.1093/cid/ciab718 Crossref PubMed Scopus (76) Google Scholar , [3] van Prehn J. Reigadas E. Vogelzang E.H. Bouza E. Hristea A. Guery B. et al. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. Clin Microbiol Infect. 2021; 27: S1-S21https://doi.org/10.1016/j.cmi.2021.09.038 Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar ]. Uptake of these recommendations remains limited in many settings because of the prohibitive cost of fidaxomicin, and different economic analyses have reached conflicting conclusions [ 4 Patel D. Senecal J. Spellberg B. Morris A.M. Saxinger L. Footer B.W. et al. Fidaxomicin to prevent recurrent Clostridioides difficile: what will it cost in the USA and Canada?. JAC Antimicrob Resist. 2023; 5: dlac138https://doi.org/10.1093/jacamr/dlac138 Crossref PubMed Scopus (3) Google Scholar , 5 Bartsch S.M. Umscheid C.A. Fishman N. Lee B.Y. Is fidaxomicin worth the cost? An economic analysis. Clin Infect Dis. 2013; 57: 555-561https://doi.org/10.1093/cid/cit346 Crossref PubMed Scopus (92) Google Scholar , 6 Reveles K.R. Backo J.L. Corvino F.A. Zivkovic M. Broderick K.C. Fidaxomicin versus vancomycin as a first-line treatment for Clostridium difficile-associated diarrhea in specific patient populations: a pharmacoeconomic evaluation. Pharmacotherapy. 2017; 37: 1489-1497https://doi.org/10.1002/phar.2049 Crossref PubMed Scopus (10) Google Scholar ]. This broader meta-analysis can potentially inform further cost-effectiveness models and clinical and policy decisions by prioritizing patient-relevant outcomes beyond recurrence.