Title

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection

Authors

Jessica Howard-Anderson, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
Weixiao Dai, The Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.
Dafna Yahav, Unit of Infectious Diseases, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
Toshimitsu Hamasaki, The Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.
Adi Turjeman, Sackler Faculty of Medicine, Tel Aviv University, Ramat-Aviv, Israel.
Fidi Koppel, Institute of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel.
Erica Franceschini, Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Modena, Italy.
Carol Hill, Duke Clinical Research Institute, Durham, North Carolina, USA.
Zoë Sund, Duke Clinical Research Institute, Durham, North Carolina, USA.
Henry F. Chambers, Department of Internal Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, California, USA.
Vance G. Fowler, Duke Clinical Research Institute, Durham, North Carolina, USA.
Helen W. Boucher, Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, USA.
Scott R. Evans, The Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.
Mical Paul, Institute of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel.
Thomas L. Holland, Duke Clinical Research Institute, Durham, North Carolina, USA.
Sarah B. Doernberg, Department of Internal Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, California, USA.

Document Type

Journal Article

Publication Date

6-1-2022

Journal

Open forum infectious diseases

Volume

9

Issue

6

DOI

10.1093/ofid/ofac140

Keywords

Gram-negative bacteremia; antibiotics; desirability of outcome ranking; treatment duration

Abstract

Background: Although a short course (7 days) of antibiotics has been demonstrated to be noninferior to a conventional course (14 days) in terms of mortality and infectious complications for patients with a Gram-negative bacterial bloodstream infection (GNB), it is unknown whether a shorter treatment duration can provide a better overall clinical outcome. Methods: We applied a bloodstream infection-specific desirability of outcome ranking (DOOR) analysis to the results of a previously completed, randomized controlled trial comparing short versus conventional course antibiotic therapy for hospitalized patients with uncomplicated GNB. We determined the probability that a randomly selected participant in the short course group would have a more desirable overall outcome than a participant in the conventional duration group. We performed (1) partial credit analyses allowing for calculated and variable weighting of DOOR ranks and (2) subgroup analyses to elucidate which patients may benefit the most from short durations of therapy. Results: For the 604 patients included in the original study (306 short course, 298 conventional course), the probability of having a more desirable outcome with a short course of antibiotics compared with a conventional course was 51.1% (95% confidence interval, 46.7% to 55.4%), indicating no significant difference. Partial credit analyses indicated that the DOOR results were similar across different patient preferences. Prespecified subgroup analyses using DOOR did not reveal significant differences between short and conventional courses of therapy. Conclusions: Both short and conventional durations of antibiotic therapy provide comparable clinical outcomes when using DOOR to consider benefits and risks of treatment options for GNB.

Department

Biostatistics and Bioinformatics

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